Study No.: Title: Rationale: Phase: Study Period Study Design: Centres: Indication: Treatment: Objectives : Primary Outcome/Efficacy Variable:
|
|
- Leon Lawson
- 6 years ago
- Views:
Transcription
1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: SLMF 4010 Title: Multicentre, randomised, parallel group, placebo-controlled, double-blind, study, stratified on tobacco status at enrollment, evaluating during 6 months the efficacy of salmeterol powder for inhalation, 50 µg two times per day for the reduction of thoracic distension in subjects with chronic obstructive pulmonary disease (COPD) Rationale: Thoracic CT-scan associated with spirometry shows structure details on bronchial and parenchymatous lesions and on bronchial dynamics during respiratory movements. The negative expiratory pressure (NEP) technique provides a simple and reliable method for detection of expiratory flow limitation. In subjects with chronic obstructive pulmonary disease (COPD), dynamic overinflation is seen when breathing demand increases and, in the most severe subjects, even at rest. The increase in total lung capacity (TLC) and functional residual capacity (FRC) and the decrease in inspiratory capacity (IC) reflects this overinflation, IC being directly correlated to the overinflation improvement. Bronchodilators are used to relieve symptoms in obstructive lung disease, such as asthma or COPD. After salbutamol inhalation in COPD subjects, the dyspnoea improvement is correlated to the IC increase and overinflation reduction. At the time of the study, there were no data on the long-term effects of salmeterol on overinflation. Phase: IV Study Period: 16 August 2001 to 01 October 2002 Study Design: Multicentre, randomised, parallel-group, placebo-controlled, double-blind study, stratified by tobacco status at enrolment. Centres: 9 centres in France Indication: Chronic Obstructive Pulmonary Disease (COPD) Treatment: meterol 50µg Diskus () and matching placebo Diskus (), with administration of one inhalation morning and evening during 24 weeks, then use of immediate bronchodilators during the 8-week follow-up period. Objectives : The objectives were: to evaluate, long term, the action of salmeterol on thoracic overinflation, to verify correlation between IC and FRC and the evolution of dyspnoea after immediate administration of salbutamol and during chronic use of salmeterol (treatment period of 24 weeks) and after stopping salmeterol during the 8 weeks follow-up period in COPD subjects with thoracic distension, to verify parallel variations of IC and FRC after 6 months of administration, to evaluate improvement of exercise capacity under salmeterol, due to a decrease of thoracic distension, to evaluate the action of salmeterol on expiratory limitation of expiratory flow with the quantified NEP, to evaluate the action of salmeterol on gasometric parameters, to evaluate the quality of life (QoL) under salmeterol, to verify correlation between QoL and thoracic distension, to explore bronchial tree with spiro CT-scan in order to argue the structural hypothesis of distension reduction mechanism in COPD subjects receiving salmeterol on long term to evaluate the safety of salmeterol Primary Outcome/Efficacy Variable: Variation of IC (in ml) before salbutamol inhalation, between visit 1 and visit 4. Secondary Outcome/Efficacy Variables: Variation in ml of IC before salbutamol inhalation, from visit 1 to visit 2, and from visit 4 to visit 6; Variation in ml of the IC difference (post salbutamol - pre salbutamol); Variation in ml of FRC measured by plethysmography before salbutamol inhalation ; Variation in ml of FRC difference (post salbutamol - pre salbutamol), FRC measured by plethysmography ; Variation in ml and in percentage of theoretical value of forced expiratory volume in one second (FEV1) before salbutamol inhalation; Variation in ml and in percentage of theoretical value of FEV1 difference (post salbutamol - pre salbutamol); Variation in ml of forced inspiratory volume in one second (FIV1) before salbutamol inhalation ; Variation in ml of FIV1 difference (post salbutamol - pre salbutamol) ; Variation in ml of Total Lung Capacity (TLC) measured by plethysmography before salbutamol inhalation Variation in ml of residual volume (RV) measured by plethysmography before salbutamol inhalation ; Dyspnoea evaluated by EEC scale at each visit ; Blood gasometry: PaO2, PaCO2, ph, HCO3-, SaO2 ; Follow-up of tobacco status through questioning and measure of expired CO at each visit ; 1
2 Follow-up of rescue medication use measured by the percentage of days with no short-acting bronchodilator use ; Qualitative and quantified NEP at each visit (depending on centre, optional): expiratory flow induced by NEP (in L/sec) and measured between 25 and 75%, at 25% and at 50% respectively of tidal volume before application of NEP (DEMNEP25-75%, DEMNEP50% and DEMNEP25%), measures were performed before and after salbutamol inhalation ; Evaluation of exercise capacity during an exercise test limited by symptoms at 50% of the maximum theoretical power (depending on centre, optional) : dyspnoea evaluated by Visual analogical scale (VAS) and IC at rest, during test, then end of test, and duration of the test, testing done before and after salbutamol inhalation ; Spiro-tomodensitometry scan (depending on centre, optional) at visit 1 and visit 4 ; Follow-up of exacerbations, including those leading to hospitalization and collection of hospital length of stay; Safety Improvement during treatment evaluated by variation of QoL measured by Saint-George s Respiratory Questionnaire (SGRQ)validated in the French language. Statistical Methods: Pre-salbutamol IC, IC difference (post salbutamol - pre salbutamol); FRC measured before salbutamol inhalation, FRC difference (post salbutamol - pre salbutamol), FEV1 before salbutamol inhalation, FEV1 difference (post salbutamol - pre salbutamol), FIV1 before salbutamol inhalation, FIV1 difference (post salbutamol - pre salbutamol), TLC before salbutamol inhalation, TLC before salbutamol inhalation, dyspnea score and Saint George questionnaire total score were tested by a repeated-measures model with treatment group and time (visit) as qualitative covariates and age, sex and smoking status as explicative covariates, interactions analyses were time (visit) and treatment, age, sex and smoking status. Adjusted mean changes were calculated by LS means. Percentage of days with no short-acting bronchodilator use was tested by a covariance analysis (ANCOVA) with treatment group, age, sex and smoking status at inclusion as covariates. No formal statistical analysis was performed for PaO2, PaCO2, ph, HCO3-, SaO2, smoking status, expired CO, COPD exacerbations which were described by mean and standard deviation for quantitative data and frequency for qualitative data. NEP, exercise test data and CT-scan data were not analyzed and were listed per subject. The ITT population included all randomised subjects having received at least one dose of study medication and for whom the assessment data for at least one assessment criterion was available and was analysed based on treatment allocated. Safety population consisted of all randomised subjects having received at least one dose of study medication and was analysed based on treatment really received. Study Population: Subjects aged more than 40 years, with tobacco habit more than 20 pack-years, with a diagnosis of COPD confirmed by a pneumologist with questioning and functional respiratory explorations and at visit 1 FEV1 > 60% of theoretical value, FEV1/TLC ratio > 75% in absolute value and > 85% of theoretical value, FEV1 reversibility >12% and >200 ml twenty minutes after 400µg of salbutamol, with an inflation defined by a FRC >110% of theoretical value. Subjects were not included with asthma and/or history of allergy including non respiratory signs, with other respiratory pathologies (bronchial cancer, interstitial pneumopathy, history of thoracic surgery, tuberculosis sequelae, pleural or parietal pathology), subjects requiring chronic oxygen therapy, subjects with severe cardiovascular disease, subjects treated within 4 weeks before enrolment with inhaled or systemic corticosteroids, β2 long-acting agonists and/or theophyllines, subjects who have presented with a COPD exacerbation and/or other acute respiratory disease within 4 weeks before enrolment, breast-feeding or potentially pregnant female. Number of Subjects: nned, N Randomised, N Completed, n (%) Total Number Subjects Withdrawn, N (%) 7 7 Withdrawn due to Adverse Events n (%) 0 2 Withdrawn due to Lack of Efficacy n (%) 1 0 Withdrawn for other reasons n (%) 6 5 Demographics N (ITT) Females: Males 1 :16 3 :14 Mean Age, years (SD) 62.9 (10.0) 64.6 (12.1) Caucasian, n (%) 17 (100) 17 (100) Primary Efficacy Results: (ITT population) Variation of inspiratory capacity (in ml) before salbutamol inhalation, between visit 1 and visit 4 2
3 Median Baseline (SE) NA NA (SE) -193 (185) 95% Confidence Interval (CI) -570; 184 p-value Secondary Outcome Variables: (ITT population) Variation (in ml) of IC before salbutamol inhalation, between -158 (158) 41 (146) (SE) -199 (215) 95% CI -639; 241 Variation (in ml) of IC before salbutamol inhalation, between 99 (123) 60 (119) (SE) 40 (171) 95% CI -570; 184 Variation (in ml) of the IC difference (post salbutamol - pre 131 (80) -32 (87) salbutamol), between visit 1 and visit 4 (SE) (SE) 163 (116) 95% CI -76; 401 Variation (in ml) of the IC difference (post salbutamol - pre 13 (134) 30 (134) salbutamol), between (SE) -17 (190) 95% CI -406; 371 Variation (in ml) of the IC difference (post salbutamol - pre -308 (109) -88 (116) salbutamol), between (SE) -220 (160) 95% CI Variation (in ml) of the FRC measured by plethysmography 150 (321) -160 (287) before salbutamol inhalation, between visit 1 and visit 4 (SE) (SE) 475 (430) 95% CI -406; 1357 Variation (in ml) of the FRC measured by plethysmography 315 (320) -160 (287) before salbutamol inhalation, between (SE) 475 (430) 95% CI -406; 1357 Variation (in ml) of the FRC measured by plethysmography -214 (221) 265 (209) before salbutamol inhalation, between (SE) -479 (303) 95% CI -1100; 142 Variation (in ml) of the difference post-salbutamol FRC presalbutamol -240 (257) -157 (253) FRC (FRC measured by plethysmography), between visit 1 and visit 4 (SE) (SE) -84 (370) 95% CI -841 ;673 Variation (in ml) of the difference post-salbutamol FRC presalbutamol -376 (253) -54 (240) FRC (FRC measured by plethysmography), between (SE) -321 (357) 95% CI -1052; 409 Variation (in ml) of the difference post-salbutamol FRC presalbutamol 201 (213) -417 (253) FRC (FRC measured by plethysmography), between (SE) 618 (329) 95% CI -57; 1292 Variation (in ml) of FEV1 before salbutamol inhalation, between visit 1 and visit 4 (SE) -94 (58) -30 (57) 3
4 (SE) -64 (81) 95% CI -230; 102 Variation (in ml) of FEV1 before salbutamol inhalation, between -107 (55) -76 (51) (SE) -30 (75) 95% CI -183; 122 Variation (in ml) of FEV1 before salbutamol inhalation between -40 (66) -124 (67) (SE) 84 (94) 95% CI -108; 275 Variation (in ml) of difference post salbutamol FEV1 - pre -29 (38) 17 (42) salbutamol FEV1, between visit 1 and visit 4 (SE) (SE) -46 (57) 95% CI -163; 70 Variation (in ml) of difference post salbutamol FEV1 - pre -14 (30) 41 (27) salbutamol FEV1, between (SE) -56 (40) 95% CI -138; 27 Variation (in ml) of difference post salbutamol FEV1 - pre 14 (28) 59 (32) salbutamol FEV1, between (SE) -45 (43) 95% CI -134; 43 Variation (in ml) of FIV1 before salbutamol inhalation, between -517 (230) 25 (185) visit 1 and visit 4 (SE) (SE) -542 (294) 95% CI -1157; 72 Variation (in ml) of FIV1 before salbutamol inhalation, between -128 (288) 119 (202) (SE) -248 (353) 95% CI -986; 490 Variation (in ml) of FIV1 before salbutamol inhalation between 338 (262) -318 (191) (SE) 657 (319) 95% CI -12; 1325 Variation (in ml) of difference post salbutamol FIV1- pre 245 (282) -102 (251) salbutamol FIV1, between visit 1 and visit 4 (SE) (SE) 347 (385) 95% CI -461; 1155 Variation (in ml) of difference post salbutamol FIV1- pre -159 (334) 167 (258) salbutamol FIV1, between (SE) -327 (420) 95% CI -1208; 555 Variation (in ml) of difference post salbutamol FIV1- pre -357 (247) 492 (232) salbutamol FIV1, between (SE) -848 (342) 95% CI -1566; -130 Variation (in ml) of TLC measured by plethysmography before 270 (454) 251 (431) salbutamol inhalation, between visit 1 and visit 4 (SE) (SE) 18 (625) 95% CI -1262; 1299 Variation (in ml) of TLC measured by plethysmography before 373 (490) -197 (444) salbutamol inhalation, between (SE) 570 (661) 95% CI -785; 1925 Variation (in ml) of TLC measured by plethysmography before salbutamol inhalation, between 353 (351) 239 (339) 4
5 (SE) 114 (487) 95% CI -884; 1111 Variation (in ml) of RV measured by plethysmography before -288 (403) -189 (395) salbutamol inhalation, between visit 1 and visit 4 (SE) (SE) -100 (564) 95% CI -1252; 1053 Variation (in ml) of RV measured by plethysmography before -152 (405) -531 (384) salbutamol inhalation, between (SE) 379 (558) 95% CI -761; 1519 Variation (in ml) of RV measured by plethysmography before -463 (431) 246 (433) salbutamol inhalation, between (SE) -709 (610) 95% CI -1955; 537 Dyspnoea evaluated by EEC scale at visit 1, mean (SD) 2.9 (0.9) 3.0 (0.9) Dyspnoea evaluated by EEC scale at visit 2, mean (SD) 3.0 (1.0) 2.6 (0.9) Dyspnoea evaluated by EEC scale at visit 3, mean (SD) 2.3 (1.0) 2.3 (0.8) Dyspnoea evaluated by EEC scale at visit 4, mean (SD) 2.7 (1.2) 2.6 (0.7) Dyspnoea evaluated by EEC scale at visit 5, mean (SD) 2.4 (1.0) 2.5 (1.2) Dyspnoea evaluated by EEC scale at visit 6, mean (SD) 2.7 (1.2) 2.9 (1.4) Blood gasometry : PaO2 (in mmhg) at visit 1, mean (SD) 75.5 (10.0) 72.3 (7.9) Blood gasometry : PaO2 (in mmhg) at visit 4, mean (SD) 72.5 (8.8) 72.3 (7.9) Blood gasometry : PaO2 (in mmhg) at visit 6, mean (SD) 71.7 (6.5) 76.7 (11.9) Blood gasometry : PaCO2 (in mmhg) at visit 1, mean (SD) 39.7 (4.5) 40.6 (4.2) Blood gasometry : PaCO2 (in mmhg) at visit 4, mean (SD) 39.0 (3.6) 40.1 (5.8) Blood gasometry : PaCO2 (in mmhg) at visit 6, mean (SD) 39.3 (3.4) 38.2 (6.0) Blood gasometry : ph at visit 1, mean (SD) (0.023) (0.020) Blood gasometry : ph at visit 4, mean (SD) (0.033) (0.026) Blood gasometry : ph at visit 6, mean (SD) (0.033) (0.052) Blood gasometry : HCO3- (in mmol/l) at visit 1, mean (SD) 24.9 (2.5) 24.5 (2.9) Blood gasometry : HCO3- (in mmol/l) at visit 4, mean (SD) 24.8 (1.9) 24.7 (2.8) Blood gasometry : HCO3- (in mmol/l) at visit 6, mean (SD) 24.1 (1.9) 23.1 (4.7) Blood gasometry : SaO2 (in %) at visit 1, mean (SD) 94.9 (1.7) 94.3 (1.5) Blood gasometry : SaO2 (in %) at visit 4, mean (SD) 94.5 (2.6) 94.0 (2.5) Blood gasometry : SaO2 (in %) at visit 6, mean (SD) 93.9 (2.0) 94.8 (2.1) Smoking status at inclusion (current smokers/former smokers), 7/10 7/10 n Smoking status during study N=15 Stopped smoking 1 1 Start again smoking 0 1 No change of smoking status Measure of expired CO (in ppm) at visit 1, mean (SD) 7.3 (7.3) 7.2 (6.5) Measure of expired CO (in ppm) at visit 2, mean (SD) 7.9 (7.2) 5.1 (5.1) Measure of expired CO (in ppm) at visit 3, mean (SD) 7.5 (7.3) 6.4 (7.2) Measure of expired CO (in ppm) at visit 4, mean (SD) 6.2 (5.3) 5.5 (5.3) Measure of expired CO (in ppm) at visit 5, mean (SD) 7.5 (8.0) 7.8 (5.5) Measure of expired CO (in ppm) at visit 6, mean (SD) 6.5 (7.2) 5.3 (4.2) Percentage of days with no short-acting bronchodilator use 41.9 (10.2) 36.2 (10.2) from week 1 to week 24, adjusted mean (SE) (SE) 5.7 (14.5) 95% CI -24.0;
6 Short-acting bronchodilator use (in puff/day) from week 1 to 2.0 (2.2) 2.6 (2.9) week 24, mean (SD) Short-acting bronchodilator use (in puff/day) from week 25 to 2.7 (1.9) 4.0 (3.4) week 32, mean (SD) DEMNEP25-75%, measures performed before and after salbutamol inhalation, in Litres per second (L/s) 95% CI DEMNEP50%, measures performed before and after salbutamol inhalation, (L/s) 95% CI DEMNEP25%, measures performed before and after salbutamol inhalation, (L/s) 95% CI Evaluation of exercise capacity during an exercise test limited by symptoms at 50% of the maximal theoretical power (depending on centre, optional) : dyspnoea evaluated by VAS (Visual analogical scale) and inspiratory capacity at rest, during test, then end of test, and duration of the test, testing done before and after salbutamol inhalation 95% CI Spiro-tomodensitometry at visit 1 95% CI Spiro-tomodensitometry at visit 4 95% CI Number of exacerbations, including those leading to hospitalization, adjusted mean Ratio meterol/placebo % CI 0.3; 1.85 Change in QoL measured by SGRQ total score from visit 1 to visit (3.7) 2.7 (3.9) -9.7 (4.6) 95% CI -20.7; 1.2 Change in QoL measured by SGRQ total score from visit 4 to 5.8 (3.0) 3.3 (3.4) visit (4.6) 95% CI -6.9; 11.8 Safety Results: An on-therapy adverse event/ serious adverse event (AE/SAE) was defined as an AE/SAE with onset on or after the start date of study medication but no later than the last date of study medication. Most Frequent Adverse Events (AEs) On-Therapy Subjects with any AE(s), n (%) 4 (24) 11 (65) n (%) n (%) Bronchitis 1 (6) 3 (18) Lower respiratory failure 0 2 (12) Serious Adverse Events (SAEs) - On-Therapy n (%) [n considered by the investigator to be related to study medication] Subjects with non-fatal SAEs, n (%) 1 (6) 3 (18) 6
7 n (%) [related] n (%) [related] Lower respiratory failure 0 2 (12) [0] Cardiac failure 0 1 (6) [0] Embolisms 0 1 (6) [0] Tachyarrhythmias 0 1 (6) [0] Fractures 0 1 (6) [0] Abdominal discomfort & Pain 1 (6) [0] 0 Colitis 1 (6) [0] 0 Gastrointestinal polyps of uncertain behaviour 1 (6) [0] 0 Nausea & vomiting 1 (6) [0] 0 Subjects with fatal SAEs, n (%) 0 0 Conclusion: No statistical evidence of a reduction of thoracic distension was demonstrated in subjects with COPD treated during 6 months with salmeterol 50µg twice daily. Four subjects presented AEs and one subject an SAE when receiving salmeterol versus 11 and 3, respectively, when receiving placebo. No deaths were reported. Publications: No Publication Date Updated: 16-Nov
Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationIndication: Treatment: Objectives: Primary Outcome/Efficacy Variable: Secondary Outcome/Efficacy Variable(s): Statistical Methods:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Co-Primary Outcomes/Efficacy Variables:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSecondary Outcome/Efficacy Variable(s):
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationUMEC/VI vs. UMEC in subjects who responded to UMEC UMEC/VI vs. VI in subjects who responded to VI
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 15 December 2010
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 December 2010 HIROBRIZ BREEZHALER 150 micrograms, inhalation powder, hard capsules B/10 with inhaler (CIP code:
More informationStudy No.: SAM40012 Title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1)
Study No.: SAM40012 Title: A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate () (mcg strength) bd via DISKUS/ACCUHALER
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis
More informationStudy No: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: SFCA3007 Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS
Study No.: A3007 Title: A Randomized, Double-Blind, -Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS Formulations of Salmeterol (SAL) 50mcg BID and Fluticasone Propionate
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationIndividual Study Table Referring to Part of the Dossier. Volume: Page:
2 CLINICAL STUDY SYNOPSIS FINAL REPORT N0. CCD-0402-RS-0002 Title of the study: Evaluation of the 24-hour trough FEV 1 following 7 days of dosing with 2 µg once daily. A multicentre, double-blind, double-dummy,
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis
More informationTORCH: Salmeterol and Fluticasone Propionate and Survival in COPD
TORCH: and Propionate and Survival in COPD April 19, 2007 Justin Lee Pharmacy Resident University Health Network Outline Overview of COPD Pathophysiology Pharmacological Treatment Overview of the TORCH
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationaclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A.
aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A. 05 October 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and
More informationBlood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial. Online Data Supplement
Blood Eosinophils and Response to Maintenance COPD Treatment: Data from the FLAME Trial Nicolas Roche, Kenneth R. Chapman, Claus F. Vogelmeier, Felix JF Herth, Chau Thach, Robert Fogel, Petter Olsson,
More informationCoexistence of confirmed obstruction in spirometry and restriction in body plethysmography, e.g.: COPD + pulmonary fibrosis
Volumes: IRV inspiratory reserve volume Vt tidal volume ERV expiratory reserve volume RV residual volume Marcin Grabicki Department of Pulmonology, Allergology and Respiratory Oncology Poznań University
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSYNOPSIS. Study center(s) This study was conducted in the United States (128 centers).
Drug product: Drug substance(s): Document No.: Edition No.: Study code: Date: SYMBICORT pmdi 160/4.5 µg Budesonide/formoterol SD-039-0725 17 February 2005 SYNOPSIS A Twelve-Week, Randomized, Double-blind,
More informationSupplementary Online Content
Supplementary Online Content Regan EA, Lynch DA, Curran-Everett D, et al; Genetic Epidemiology of COPD (COPDGene) Investigators. Clinical and radiologic disease in smokers with normal spirometry. Published
More informationPulmonary Function Testing: Concepts and Clinical Applications. Potential Conflict Of Interest. Objectives. Rationale: Why Test?
Pulmonary Function Testing: Concepts and Clinical Applications David M Systrom, MD Potential Conflict Of Interest Nothing to disclose pertinent to this presentation BRIGHAM AND WOMEN S HOSPITAL Harvard
More informationRoflumilast (Daxas) for chronic obstructive pulmonary disease
Roflumilast (Daxas) for chronic obstructive pulmonary disease August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended
More informationIndividual Study Table Referring to Part of the Dossier. Volume:
Final Report M/100977/21Final Version () 2. SYNOPSIS A Title of Study: A PHASE IIa, RANDOMISED, DOUBLE-BLIND, MULTIPLE DOSE, PLACEBO CONTROLLED, 3 PERIOD CROSS-OVER, ASCENDING DOSE CLINICAL TRIAL TO ASSESS
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationAclidinium bromide/ formoterol Benefit assessment according to 35a Social Code Book V 1
IQWiG Reports Commission No. A15-06 Aclidinium bromide/ formoterol Benefit assessment according to 35a Social Code Book V 1 Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Aclidiniumbromid/Formoterol
More information6- Lung Volumes and Pulmonary Function Tests
6- Lung Volumes and Pulmonary Function Tests s (PFTs) are noninvasive diagnostic tests that provide measurable feedback about the function of the lungs. By assessing lung volumes, capacities, rates of
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationStudy No: Title: Rationale: . Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSYNOPSIS. Co-ordinating investigator Not applicable. Study centre(s) This study was conducted in Japan (57 centres).
Drug product: Symbicort Turbuhaler Drug substance(s): ST (Symbicort Turbuhaler ) Edition No.: 1.0 Study code: D5890C00010 Date: 15 March 2007 SYNOPSIS An 8-week, randomised, double blind, parallel-group,
More informationTeacher : Dorota Marczuk Krynicka, MD., PhD. Coll. Anatomicum, Święcicki Street no. 6, Dept. of Physiology
Title: Spirometry Teacher : Dorota Marczuk Krynicka, MD., PhD. Coll. Anatomicum, Święcicki Street no. 6, Dept. of Physiology I. Measurements of Ventilation Spirometry A. Pulmonary Volumes 1. The tidal
More informationAclidinium bromide/formoterol Endpoint category. RR Endpoint. [95% CI 2 ] Study. with event
Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationD DAVID PUBLISHING. 1. Introduction
Journal of Health Science 2 (2014) 591-598 doi: 10.17265/2328-7136/2014.12.004 D DAVID PUBLISHING Comparative Efficacy and Safety of Two Formulations of Ipratropium Bromide (IB) HFA pmdi in Patients with
More informationSurveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved.
Surveillance report 2016 Chronic obstructive pulmonary disease in over 16s: diagnosis and management (2010) NICE guideline CG101 Surveillance report Published: 6 April 2016 nice.org.uk NICE 2016. All rights
More informationLead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984]
Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984] 1 st Appraisal Committee meeting Background & Clinical Effectiveness John McMurray 11 th January 2016 For
More informationSYNOPSIS THIS IS A PRINTED COPY OF AN ELECTRONIC DOCUMENT. PLEASE CHECK ITS VALIDITY BEFORE USE.
Drug product: Drug substance(s): Document No.: Edition No.: 1 Study code: Accolate Zafirlukast (ZD9188) 9188IL/0138 Date: 02 May 2007 SYNOPSIS A Multicenter, Randomized, Double-blind, -controlled, Parallel
More informationSupplementary Online Content
Supplementary Online Content Deslée G, Mal H, Dutau H, et al; REVOLENS Study Group. Lung volume reduction coil treatment vs usual care in patients with severe emphysema: the REVOLENS randomized clinical
More informationStudy No Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable(s):
Studies listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSGRQ Questionnaire assessing respiratory disease-specific quality of life. Questionnaire assessing general quality of life
SUPPLEMENTARY MATERIAL e-table 1: Outcomes studied in present analysis. Outcome Abbreviation Definition Nature of data, direction indicating adverse effect (continuous only) Clinical outcomes- subjective
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
Study No.: 29060/717 Title: A Double-Blind, Placebo-Controlled, 3-Arm, Fixed-Dose Study of CR Intermittent Dosing (12.5 mg and 25 mg) for Premenstrual Dysphoric Disorder Rationale: In most trials investigating
More informationSYNOPSIS. Drug substance(s) Budesonide/formoterol Document No. Edition No. Study code SD Date 16 December 2004
Drug product SYMBICORT pmdi 160/4.5 µg SYNOPSIS Drug substance(s) Budesonide/formoterol Document No. Edition No. Date 16 December 2004 A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled
More informationSYNOPSIS. First subject enrolled 15 August 2003 Therapeutic confirmatory (III) Last subject completed 03 February 2005
Drug product: SYMBICORT pmdi 160/4.5 μg Drug substance(s): Budesonide/formoterol Study code: SD-039-0728 Edition No.: FINAL Date: 27 February 2006 SYNOPSIS A 52-week, randomized, double-blind, single-dummy,
More informationClinical and radiographic predictors of GOLD-Unclassified smokers in COPDGene
Clinical and radiographic predictors of GOLD-Unclassified smokers in COPDGene Emily S. Wan, John E. Hokanson, James R. Murphy, Elizabeth A. Regan, Barry J. Make, David A. Lynch, James D. Crapo, Edwin K.
More informationPFT Interpretation and Reference Values
PFT Interpretation and Reference Values September 21, 2018 Eric Wong Objectives Understand the components of PFT Interpretation of PFT Clinical Patterns How to choose Reference Values 3 Components Spirometry
More informationChronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease 07 Contributor Dr David Tan Hsien Yung Definition, Diagnosis and Risk Factors for (COPD) Differential Diagnoses Goals of Management Management of COPD THERAPY AT EACH
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 25 May 2011
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 25 May 2011 Examination of the file for the proprietary medicinal product included for a period of 5 years by the
More informationPulmonary and Critical Care Year in Review
Pulmonary and Critical Care Year in Review Heath E Latham, MD Assistant Professor University of Kansas Dept of Internal Medicine Division of Pulmonary and Critical Care None Disclosure Lung Cancer Screening
More informationStudy No.:MPX Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationDecramer 2014 a &b [21]
Buhl 2015 [19] Celli 2014 [20] Decramer 2014 a &b [21] D Urzo 2014 [22] Maleki-Yazdi 2014 [23] Inclusion criteria: Diagnosis of chronic obstructive pulmonary disease; 40 years of age or older; Relatively
More informationStep-down approach in chronic stable asthma: A comparison of reducing dose Inhaled Formoterol/ Budesonide with maintaining Inhaled Budesonide.
Step-down approach in chronic stable asthma: A comparison of reducing dose Inhaled Formoterol/ Budesonide with maintaining Inhaled Budesonide. By: DR MOHD SHAMSUL AMRI Supervisor: Associate Professor Dr
More informationรศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น
รศ. นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล ยขอนแก น COPD Guideline Changing concept in COPD management Evidences that we can offer COPD patients better life COPD Guidelines
More informationSUMMARY THIS IS A PRINTED COPY OF AN ELECTRONIC DOCUMENT. PLEASE CHECK ITS VALIDITY BEFORE USE.
i SUMMARY ZENECA PHARMACEUTICALS FINISHED PRODUCT: ACTIVE INGREDIENT: ACCOLATE zafirlukast (ZD9188) Trial title (number): A Dose-ranging, Safety and Efficacy Trial with Zafirlukast (ACCOLATE ) in the Treatment
More informationumeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline
umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) GlaxoSmithKline 07 November 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationLecture Notes. Chapter 4: Chronic Obstructive Pulmonary Disease (COPD)
Lecture Notes Chapter 4: Chronic Obstructive Pulmonary Disease (COPD) Objectives Define COPD Estimate incidence of COPD in the US Define factors associated with onset of COPD Describe the clinical features
More informationInterventional procedures guidance Published: 20 December 2017 nice.org.uk/guidance/ipg600
Endobronchial valve insertion to reduce lung volume in emphysema Interventional procedures guidance Published: 20 December 2017 nice.org.uk/guidance/ipg600 Your responsibility This guidance represents
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of insertion of endobronchial nitinol coils to improve lung function in emphysema
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe Relationship among COPD Severity, Inhaled Corticosteroid Use, and the Risk of Pneumonia.
The Relationship among COPD Severity, Inhaled Corticosteroid Use, and the Risk of Pneumonia. Rennard, Stephen I; Sin, Donald D; Tashkin, Donald P; Calverley, Peter M; Radner, Finn Published in: Annals
More informationFunctional Respiratory Imaging
Functional Respiratory Imaging (FRI) to assess the bioequivalence of inhaled medication Jan De Backer, MSc, PhD, MBA CEO BABE 2014 Functional Respiratory Imaging (FRI) FRI outcome parameters Added value
More informationSYNOPSIS. Date 15 June 2004
Drug product Drug substance(s) Document No. Edition No. Study code SYMBICORT pmdi 160/4.5 mg per actuation Budesonide/formoterol SD-039-0719 Date 15 June 2004 SYNOPSIS A Six-Month, Randomized, Open-Label
More informationCOPD. Breathing Made Easier
COPD Breathing Made Easier Catherine E. Cooke, PharmD, BCPS, PAHM Independent Consultant, PosiHleath Clinical Associate Professor, University of Maryland School of Pharmacy This program has been brought
More informationCOPD in primary care: reminder and update
COPD in primary care: reminder and update Managing COPD continues to be a major feature of primary care, particularly in practices with a high proportion of M ori and Pacific peoples. COPDX clinical practice
More informationProductivity losses in chronic obstructive pulmonary disease a population-based survey.
Online supplement to Productivity losses in chronic obstructive pulmonary disease a population-based survey. Running head: Productivity losses in COPD. Authors: Marta Erdal, Department of Thoracic Medicine,
More informationWhat do pulmonary function tests tell you?
Pulmonary Function Testing Michael Wert, MD Assistant Professor Clinical Department of Internal Medicine Division of Pulmonary, Critical Care, and Sleep Medicine The Ohio State University Wexner Medical
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION (FLUTICASONE FUROATE/VILANTEROL) (Breo Ellipta GlaxoSmithKline) Indication: Chronic Obstructive Pulmonary Disease Recommendation: The Canadian Drug Expert Committee (CDEC) recommends
More informationChronic Obstructive Pulmonary Disease (COPD) KAREN ALLEN MD PULMONARY & CRITICAL CARE MEDICINE VA HOSPITAL OKC / OUHSC
Chronic Obstructive Pulmonary Disease (COPD) KAREN ALLEN MD PULMONARY & CRITICAL CARE MEDICINE VA HOSPITAL OKC / OUHSC I have no financial disclosures Definition COPD is a preventable and treatable disease
More informationStudy Population: 12 years and older A EF Calcipotriene Foam, 0.005%
Study No.: CAL.203 Title: A Randomized, Open-Label Study to Assess the Bioavailability of Emulsion Formulation Foam, 0.005%, and Dovonex, 0.005%, in Patients with Mild to Moderate Plaque-Type Psoriasis
More informationIs reslizumab effective in improving quality of life and asthma control in adolescent and adult patients with poorly controlled eosinophilic asthma?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 2018 Is reslizumab effective in improving
More informationSYNOPSIS A two-stage randomized, open-label, parallel group, phase III, multicenter, 7-month study to assess the efficacy and safety of SYMBICORT
Drug product: Drug substance(s): Edition No.: Study code: SYMBICORT pmdi 160/4.5 g Budesonide/formoterol D5896C00005 Date: 8 May 2006 SYNOPSIS A two-stage randomized, open-label, parallel group, phase
More informationAWMSG SECRETARIAT ASSESSMENT REPORT. Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder. Reference number: 938 FULL SUBMISSION
AWMSG SECRETARIAT ASSESSMENT REPORT Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder Reference number: 938 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics
More informationExacerbations of COPD. Dr J Cullen
Exacerbations of COPD Dr J Cullen Definition An AECOPD is a sustained worsening of the patient s clinical condition from their stable state that is beyond their usual day-to-day variation is acute in onset
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationLong Term Care Formulary RS -29
RESTRICTED USE Asthma/COPD Management 1 of 6 PROTOCOL: Asthma Glossary of Medication Acronyms: SABA: short-acting beta agonist (e.g. salbutamol) SABD: short-acting bronchodilator (e.g. ipratropium or SABA)
More informationroflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd
roflumilast 500 microgram tablets (Daxas ) SMC No. (635/10) Nycomed Ltd 06 August 2010 (Issued 10 September 2010) The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationRESPIRATORY PHYSIOLOGY Pre-Lab Guide
RESPIRATORY PHYSIOLOGY Pre-Lab Guide NOTE: A very useful Study Guide! This Pre-lab guide takes you through the important concepts that where discussed in the lab videos. There will be some conceptual questions
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationII: Moderate Worsening airflow limitations Dyspnea on exertion, cough, and sputum production; patient usually seeks medical
Table 3.1. Classification of COPD Severity Stage Pulmonary Function Test Findings Symptoms I: Mild Mild airflow limitations +/ Chronic cough and sputum production; patient unaware of abnormal FEV 1 80%
More informationTreatment. Assessing the outcome of interventions Traditionally, the effects of interventions have been assessed by measuring changes in the FEV 1
58 COPD 59 The treatment of COPD includes drug therapy, surgery, exercise and counselling/psychological support. When managing COPD patients, it is particularly important to evaluate the social and family
More informationPULMONARY FUNCTION TEST(PFT)
PULMONARY FUNCTION TEST(PFT) Objectives: By the end of the present lab, students should be able to: 1. Record lung volumes and capacities and compare them with those of a typical person of the same gender,
More informationHM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics>
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationChronic Obstructive Pulmonary Disease (COPD).
Chronic Obstructive Pulmonary Disease (COPD). Linde: Living healthcare 02 03 Chronic Obstructive Pulmonary Disease (COPD). A pocket guide for healthcare professionals. COPD the facts Moderate to severe
More informationSpirometry. Obstruction. By Helen Grim M.S. RRT. loop will have concave appearance. Flows decreased consistent with degree of obstruction.
1 2 Spirometry By Helen Grim M.S. RRT 3 4 Obstruction loop will have concave appearance. Flows decreased consistent with degree of obstruction. Volumes may be normal, but can decrease with severity of
More informationChronic obstructive pulmonary disease (COPD) is characterized
DANIEL E. HILLEMAN, PharmD ABSTRACT OBJECTIVE: To review the role of long-acting bronchodilators in the treatment of chronic obstructive pulmonary disease (COPD), including the importance of treatment
More informationThey are updated regularly as new NICE guidance is published. To view the latest version of this NICE Pathway see:
bring together everything NICE says on a topic in an interactive flowchart. are interactive and designed to be used online. They are updated regularly as new NICE guidance is published. To view the latest
More informationCOPD: Current Medical Therapy
COPD: Current Medical Therapy Angela Golden, DNP, FNP-C, FAANP Owner, NP from Home, LLC Outcomes As a result of this activity, learners will be able to: 1. List the appropriate classes of medications for
More informationSpirometry: Introduction
Spirometry: Introduction Dr. Badri Paudel 1 2 GMC Spirometry Spirometry is a method of assessing lung function by measuring the volume of air the patient can expel from the lungs after a maximal expiration.
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationDATE: 09 December 2009 CONTEXT AND POLICY ISSUES:
TITLE: Tiotropium Compared with Ipratropium for Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease: A Review of the Clinical Effectiveness DATE: 09 December 2009 CONTEXT AND POLICY
More information