The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
|
|
- MargaretMargaret Amelia Cooper
- 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. GSK Medicine: GW GSK () Study Number: Title: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination with Fluticasone Furoate in COPD Subjects with an Asthmatic Component Rationale: In order to provide a treatment option for COPD patients with an asthmatic component., the combination of a once-daily inhaled corticosteroid (FF, GW685698) and a once-daily long-acting muscarinic antagonist (UMEC, GSK573719) is being studied, and its effect compared to FF alone and to the combination of FF and the once-daily long acting beta2- agonist vilanterol (VI, GW642444). Phase: IIb Study Period: 15-July July 2015 Study Design: Multicenter, randomized, double-blind, parallel-group dose-ranging study to evaluate the dose-response of four doses of UMEC in combination with FF (,,, and 0 mcg), compared with mcg monotherapy in COPD subjects with an asthmatic component. Centres: 55 centers in seven countries (5 in Argentina, 6 in Germany, 7 in Poland, 10 in Romania, 10 Russia, 7 in Ukraine, and 10 in the United States) Indication: COPD with an asthmatic component Treatment: Four-week run-in with fluticasone/salmeterol 250/50 mcg combination, after which subjects were randomized to receive one of 24 possible treatment sequences. Eligible subjects were randomized in Phase A (in a 1:1:1:1:2:2 ratio) to mcg, mcg, mcg, mcg, 0 mcg, or mcg, respectively. After 4 weeks of treatment, subjects entered Phase B and received either 0 mcg or /VI 0/25 mcg for 1 week. Subjects then entered Phase C where they received either the same treatment in Phase B or the same treatment minus the UMEC component for 1 week. Objectives: The primary objective of this study was to evaluate the dose-response of once-daily UMEC (15.6, 62.5, 125 and 250 mcg) in combination with, compared to mcg monotherapy over a 4-week treatment period (i.e. Phase A) in COPD subjects with an asthmatic component. Primary Outcome (Endpoints)/Efficacy : Change from Baseline in trough FEV1 at the end of Phase A (Visit 6) Secondary Outcome (Endpoints)/Efficacy: Mean change from baseline in rescue medication use at the end of Treatment Phase A Mean change from baseline in EXACT-RS score at the end of Treatment Phase A Change from baseline in daily morning (AM) PEF (pre-dose and pre-rescue bronchodilator) measured at home and averaged over the last 21 days of Treatment Phase A Change from trough in FEV1 at 3 hours post-study treatment at Visit 5 Change in clinic FEV1 following 2 puffs of albuterol/salbutamol given 3 hours post-study treatment dose at Visit 5 Statistical Methods: The primary comparisons of interest were between each of the four doses of and FF alone for the primary endpoint of change from baseline in clinic trough FEV1 at the end of Phase A (Visit 6) for the Intent-to-treat (ITT) Population. Sample size was determined based on the simulation results for the probability of observing a difference of at least 150 ml from for each dose of and the precision of estimations for these treatment comparisons. A total of 10,000 simulations were run for a variety of scenarios based on the treatment effect sizes observed in GSK study ILA Each simulation assumed that the standard deviation of change in trough FEV1 was 350 ml; six treatment arms were included in the study (FF100, 15.6 or 31.25, 62.5, 125, 250, and ), and the number randomized to each treatment arm was varied with twice as many assigned to the 250 and arms (i.e., 1:1:1:1:2:2 allocation ratio, respectively). The increase in precision for the treatment comparisons appeared to be small when n>40 per arm. The covariates included in the final dose response model to assess their effect on the primary efficacy endpoint were age (years), sex, baseline FEV1, pack-years smoked and age when first treated with an inhaler per randomization stratification. The ITT population consisted of all subjects randomized to treatment and who received at least one dose of study medication. This constituted the primary population for all analyses of efficacy measures and safety measures during Phase A. The Phase B Population comprised all ITT subjects who completed Phase A according the protocol and received at least one dose of Phase B study treatment. This constituted the primary population for all analyses of efficacy measures and safety measures during Phase B. The Phase C Population comprised all ITT subjects who completed Phase B according the protocol and received at least one dose of Phase C study treatment. This constituted the primary population for all analyses of efficacy measures and safety measures during Phase C. The primary dose response analysis included clinic FEV1 data at baseline and trough FEV1 data at the end of treatment Phase A. The 1
2 dose response models included the null model, the step model, the slope-intercept model, the slope-intercept model on log scale, the Emax model, and the sigmoidal Emax model. The final dose response model was selected based on the minimum value for Akaike information criterion (AIC). Change from baseline in trough FEV1 at the end of Treatment Phase A was analyzed based on the final dose response model using SAS procedure for non-linear mixed effect model. The mean difference between each given dose of (or ) and FF for the change from baseline in trough FEV1 was predicted based on the final selected dose-response model, adjusted for the covariates age (years), sex, baseline FEV1, pack years smoked and age when first treated with an inhaler per randomization stratification. The Analysis of Covariance (ANCOVA) was also performed as a sensitivity analysis for the primary efficacy endpoint, and was the analysis method for all secondary efficacy endpoints of the continuous type variables, adjusted for all covariates mentioned above. The number and percentage of subjects experiencing at least one AE of any type, AEs within each body system and AEs within each preferred term were presented for each treatment group. Separate summaries were provided for all AEs, drug-related AEs, SAEs, and AEs leading to withdrawal, fatal AEs, most frequent AEs and AEs of special interest (relating to potential pharmacological class effects). All SAEs were tabulated and listed by treatment group. Deaths and SAEs were documented in case narrative format. Vital signs (pulse rate, systolic and diastolic blood pressure), ECGs and COPD exacerbations were summarized by treatment group. Study Population: Male and non-pregnant female outpatients (smokers or non-smokers), aged 18 years with a sufficient medical history to diagnose the subject as having COPD in accordance with the American Thoracic Society/European Respiratory Society definitions, with evidence of an asthmatic component as demonstrated by a best post-bronchodilator morning FEV1 50% and 80% of the predicted normal value at Visit 1 and a pre- and post-bronchodilator FEV1/FVC ratio <0.7 at Visit 1. Subjects were also required to demonstrate reversibility of their disease, defined by a 12% and 200 ml increase in FEV1 between 20 and 60 minutes following four inhalations of albuterol/salbutamol at Visit 1. Number of Subjects in Phase A (ITT Population): 0 Total Planned, N Randomised, N (37) Completed, n (% ) 39 (95) 42 (100) 39 (98) 44 (96) 82 (96) 83 (99) 329 (97) Withdrawn, n (%) 1 2 (5) 0 1 (3) 2 (4) 3 (4) 1 (1) 9 (3) Withdrawn: Adverse Events n (%) (3) 1 (2) (<1) Withdrawn: Lack of Efficacy n (%) (1) 0 1 (<1) Withdrawn: subject reached 1 (2) (2) 0 1 (1) 3 (<1) protocol-defined stopping criteria Withdrawn: by subject n (%) 1 (2) (2) 0 3 (<1) 1. In Phase B, four subjects (1%) were withdrawn; two of these (<1%) due to an AE that occurred while receiving 0. One subject (<1%) receiving 0 was withdrawn due to subject reaching protocol stopping criteria and one subject receiving /VI was withdrawn due to physician decision. In Phase C, 3 subjects (<1%) were withdrawn from treatment: 1 (1%) receiving FF100 (withdrawal by subject), and 2 (3%) receiving /VI 0/25 (one due to AE, one due to physician decision). Demographics in Phase A (ITT population) N Females: Males 21:20 23:19 19:21 18:28 38:47 41:43 160:178 Mean Age, years (SD) (8.59) (11.33) (10.14) (10.47) (11.03) (10.95) (10.56) White, n (%) 40 (98) 42 (100) 39 (98) 45 (98) 81 (95) 83 (99) 330 (98) Primary Efficacy Results (ITT Population): Analysis of Change from Baseline in Clinic Trough FEV1 (L) at the End of Phase A (Final Step Model) 0 Final Step Model (Primary) n Mean Difference from % C.I. (0.014,0.193) (0.014,0.193) (0.014,0.193) (0.014,0.193) (-0.027,0.172) p-value
3 ANCOVA Analysis of Change from Baseline in Clinic Trough FEV1 (L) at the End of Phase A 0 n LS mean (SE) (0.0441) (0.0448) (0.0454) (0.0416) (0.0325) (0.0331) LS mean change (SE) (0.0441) (0.0448) (0.0454) (0.0416) (0.0325) (0.0331) Column vs. Difference (-0.032, (0.023, (0.006, (-0.016, (-0.029, 0.201) 0.258) 0.234) 0.186) 0.173) p-value Secondary Efficacy Results (ITT Population): Analysis of Change from Baseline in Rescue Medication Use (puffs) at the End of Phase A 0 Daily rescue medication use (puffs) n LS Mean (SE) 3.4 (0.29) 2.4 (0.29) 2.3 (0.29) 2.7 (0.27) 2.6 (0.21) 2.7 (0.21) LS Mean change (SE) 0.6 (0.29) -0.4 (0.29) -0.5 (0.29) 0.0 (0.27) -0.2 (0.21) -0.1 (0.21) Column vs. Difference (-1.7,-0.2) (-1.9,-0.4) (-1.4,0.1) (-1.5,-0.2) (-1.4,-0.1) Analysis of Change from Baseline in EXACT-RS Scores at the End of Phase A EXACT-RS Total Score 0 n LS Mean (SE) 11.3 (0.54) 8.2 (0.55) 8.2 (0.56) 9.3 (0.52) 9.3 (0.40) 9.6 (0.41) LS Mean Change (SE) 0.5 (0.54) -2.6 (0.55) -2.5 (0.56) -1.5 (0.52) -1.5 (0.40) -1.1 (0.41) Column vs. Difference (-4.6,-1.7) (-4.5,-1.6) (-3.4,-0.6) (-3.2,-0.7) (-2.9,-0.4) Total score range: 0 to 40, higher scores indicate more severe symptoms Analysis of Change from Baseline in AM PEF (L/min) Averaged Over the Last 21 Days of Phase A AM PEF 0 n LS Mean (SE) (4.62) (4.70) (4.76) (4.40) (3.37) (3.47) LS Mean Change (SE) -14.2(4.62) 3.9(4.70) 7.6(4.76) 5.5(4.40) 10.5(3.37) 4.3(3.47) Column vs. Difference (5.9, 30.3) (9.4, 34.1) (7.7, 31.7) (14.1, 35.4 (8.0, 29.1) PM PEF 3
4 n LS Mean (SE) (5.22) (5.41) (5.38) (4.99) (3.83) (3.92) LS Mean Change (SE) -14.3(5.22) 6.2(5.41) 18.3(5.38) 10.0 (4.99) 13.5 (3.83) 12.5 (3.92) Column vs. Difference , , , , , 38.7 Analysis of Change from Trough in Clinic FEV1 (L) at 3 Hours Post-study Treatment at Visit 5 (Day 28) Visit 5 Day 28 0 N=41 N=42 N=40 N=46 N=85 N=84 Trough n Mean SD At 3 hours post-study treatment Visit 5 Day 28 n LS Mean Standard Error LS Mean Change Standard Error Treatment vs. Difference , , , , , Treatment vs. Difference , , , , Analysis of Change from Pre-Albuterol/Salbutamol in Clinic FEV1 (L) Following Two Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment at Visit 5 (Day 28) Visit 5 (Day 28) 0 n LS Mean Standard Error LS Mean Change Standard Error Column vs. FF Difference , , , , , Column vs. Difference , 0.009, 0.012, 0.052, Safety Results: Adverse events and SAEs were collected from the start of the run-in period until the follow-up contact. Ontreatment AEs were defined as occurring up to and including 1 day after the last dose of study medication taken. Any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication were recorded from the time a subject consented to participate in the study up to and including any follow up contact. All AEs and SAEs were followed until resolution, until the condition stabilized, until the event was otherwise explained, or until the subject was lost to follow up 4
5 Most Frequent Adverse Events On-Therapy (ITT Population) FF/ UMEC 0 Any AE(s), n(%) 13 (32) 13 (31) 8 (20) 11 (24) 13 (15) 17 (20) Nasopharyngitis 5 (12) 3 (7) 2 (5) 2 (4) 2 (2) 4 (5) Dysgeusia 1 (2) 0 1 (3) 1 (2) 2 (2) 1 (1) Headache 1 (2) 2 (5) 1 (3) 1 (2) 1 (1) 0 Dysphonia 1 (2) 0 1 (3) 3 (7) 0 0 Cough 2 (5) (2) 0 2 (2) Back pain 0 1 (2) 1 (3) 0 1 (1) 0 Toothache 0 3 (7) 1 (3) Respiratory tract infection (2) 0 2 (2) Upper respiratory tract 1 (2) (2) infection Throat irritation 1 (2) (1) 0 Nasal congestion (3) (1) Rhinitis 1 (2) 1 (2) Respiratory tract infection viral 2 (5) Oropharyngeal pain 1 (2) 1 (2) Respiratory disorder (2) 0 1 (1) Rash (4) 0 0 Arthropod bite 0 1 (2) (1) Periodontitis (3) Bronchitis (1) Gingivitis (2) 0 0 Influenza (1) 0 Oral candidiasis 0 1 (2) Pharyngotonsillitis (1) 0 Sinusitis 1 (2) Viral upper respiratory tract (2) 0 0 infection Chronic obstructive pulmonary disease 1 (2) Pulmonary congestion 1 (2) Dizziness (1) 0 Abdominal pain upper (1) 0 Diarrhoea (1) 0 Dry mouth (1) Inguinal hernia (2) 0 0 Pain in extremity (1) 0 Arrhythmia (2) 0 0 Atrial fibrillation 0 1 (2) Palpitations (1) Pruritus (1) Chest discomfort (3) Non-cardiac chest pain 1 (2) Hyperglycaemia (1) 0 Hyperkalaemia (3) Anxiety (3) Insomnia (1) Vertigo 1 (2) Blood glucose increased 0 1 (2)
6 Serious Adverse Events - On-Therapy n (%) [n considered by the investigator to be related to study medication] Non-fatal on-treatment SAEs FF/ UMEC 0 Hypertensive crisis (<1) [0] 0 There were no on-treatment fatal SAEs. Conclusion: For the primary endpoint of trough FEV1 at Visit 6, statistically significant improvements from baseline in trough FEV1 were demonstrated (by modelling) for all four treatments when compared with treatment. The final step model predicted a mean increase of 103 ml in trough FEV1 for each treatment compared with FF alone at Visit 6, (p=0.024). In the ANCOVA analysis of the primary endpoint of trough FEV1 at Visit 6, improvements in trough FEV1 were observed for all treatments, ranging from 85 ml to 140 ml with the treatments and 72 ml with the treatment, with statistically significant LS mean differences over being demonstrated for the and treatments (140 ml and 120 ml, respectively). The improvement in trough FEV1 did not reach 150 ml for any of treatments when compared to. However, the improvement did exceed 50 ml for when compared to the next lower dose of () and to the treatment. In the ITT population, the effect of treatment with compared to reached a plateau at the 62.5 mcg UMEC dose. The LS mean changes in trough FEV1 demonstrated with the treatments were similar to or greater than the change observed with the treatment. The results of the primary endpoint were also supported by the secondary endpoints: LS mean reductions from Baseline in rescue medication use (puffs/day) when compared to ranged from 0.7 to 1.1 puffs for all groups and and were statistically significant for all treatment groups except. Clinically meaningful and statistically significant LS mean changes (decreases) in the EXACT-RS total scores were demonstrated for all of the treatments and the treatment compared with. LS mean improvements in PEF when compared to ranged from 18.1 to 24.8 L/min in groups and 18.5 L/min in group for the AM assessments, and from 20.5 to 32.6 L/min in groups and 26.8 L/min in group for the PM assessments; these improvements were statistically significant. For the secondary endpoint of change from trough in FEV1 at three hours post-study treatment on Visit 5, LS mean increases were observed in all treatments, ranging from 5 to 45 ml in the groups and 76 ml in when compared to FF. These increases were not statistically significant. The secondary endpoint of change in clinic FEV1 following two puffs of albuterol measured albuterol responses on backgrounds of ICS/LABA and ICS/LAMA on Day 28. LS mean changes for the groups when compared to ranged from 73mL to 103 ml; a statistically significant treatment difference was observed in favor of all treatments. The clinical significance of this difference is uncertain. The most commonly reported AEs in the ITT population were nasopharyngitis, viral respiratory tract infection, cough, and dysphonia. Non-serious AEs were reported for each treatment group (by study phase) as follows: Phase A FF/ UMEC 0 Any AE n (%) 13 (32) 13 (31) 8 (20) 11 (24) 13 (15) 17 (20) 0 /VI 0/25 Phase B (N=166) (N=163) Any AE n (%) 15 (9) 9 (6) Phase C (N=79) 0 (N=82) /VI 0/25 (N=80) Any AE n (%) 3 (4) 2 (2) 3 (4) 3 (4) There was one on-treatment, non-fatal SAE in Phase B during treatment with 0 (hypertensive crisis). There were no on-treatment fatal events; however, one post-treatment death was reported for a subject 20 days after they 6
7 had been withdrawn from the study due to an unspecified AE. The subject experienced the non-fatal SAE of pneumonia 2 days after withdrawal; although this SAE was reported to have resolved, the subject experienced two further SAEs that were reported as having a fatal outcome: transient ischemic attack and pulmonary embolism, which had dates of onset 14 and 17 days, respectively, after the last dose of study medication. Of these two fatal SAEs, the pulmonary embolism was reported to be an underlying cause of death. The investigator considered the SAEs of pneumonia and pulmonary embolism related to treatment. 7
UMEC/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 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 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 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: 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 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 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 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 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 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 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 informationEvidence Summary to support COPD formulary decision making and guideline development
Evidence Summary to support COPD formulary decision making and guideline development Prescribing and adverse event reporting information can be found on the final pages of this document. Anoro, and Ellipta
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 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 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 informationEvidence Summary to support COPD formulary decision making and guideline development
Evidence Summary to support COPD formulary decision making and guideline development Prescribing and adverse event reporting information can be found on the final page of this document. Trelegy and Ellipta
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 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 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 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 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 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 informationThe only COPD Triple Therapy delivered in a single daily inhalation. 1 Improvement in quality of life vs. ICS/LABA. 2
The only COPD Triple Therapy delivered in a single daily inhalation. 1 Improvement in quality of life vs. ICS/LABA. 2 Trelegy Ellipta is indicated for maintenance treatment in adult patients with moderate-to-severe
More informationInforMing the PAthway of COPD Treatment 1
InforMing the PAthway of COPD Treatment 1 A landmark trial in over 10,000 symptomatic COPD patients who had experienced at least one exacerbation in the last 12 months 1 (fluticasone furoate/umeclidinium/vilanterol)
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 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: 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 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 informationAnalysis of immunogenicity
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 Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective:
GSK Medicine: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) Study Number: 201147 Title: A IIIb, randomized, open-label study of the safety, efficacy, and tolerability of switching to a fixed-dose
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 informationGSK Medicine: Study Number:
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 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 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 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 informationmg 25 mg mg 25 mg mg 100 mg 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.
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 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 informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN VI.1 Summary of risk management plan for RELVAR ELLIPTA (fluticasone furoate/vilanterol) This is a summary of the risk management plan (RMP) for RELVAR ELLIPTA.
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period Study Design: Group 1 (Test Group) Group 2 (Reference group):
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 was a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study.
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 informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See United States Package Insert (USPI)
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
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 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 informationSYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only)
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20 mg) multicenter study of long-term glycemic control with rimonabant in treatment-naïve
More informationRelvar Ellipta (fluticasone furoate/vilanterol [as trifenatate]) for the treatment of patients with asthma
Relvar Ellipta (fluticasone furoate/vilanterol [as trifenatate]) for the treatment of patients with asthma Evidence Summary to support formulary decision making and guideline development Prescribing and
More informationIncruse Ellipta 55mcg (umeclidinium bromide) for the relief of symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD):
Incruse Ellipta 55mcg (umeclidinium bromide) for the relief of symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD): An introduction for Clinical Commisioning Groups and Health
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 informationumeclidinium/vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) GlaxoSmithKline
umeclidinium/vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) GlaxoSmithKline 04 July 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above 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 informationTreatment B: FF (400 µg) and UMEC (250 µg)/vi(100 µg) The indicated dose is the total of four inhalations via the dry powder inhaler.
GSK Medicine:GSK573719 (Umeclidinium)+ GW6424 (Vilanterol) + GW685698 (Fluticasone furoate) Study Number: 200587 Title: An open label, randomised, four-period crossover, single dose study in healthy volunteers
More informationThree s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD)
Three s Company - The role of triple therapy in chronic obstructive pulmonary disease (COPD) Zahava Picado, PharmD PGY1 Pharmacy Practice Resident Central Texas Veterans Healthcare System Temple, TX October
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 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 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 informationSecondary efficacy endpoints for Part 2, the Eltrombopag-Only Period, included the proportion of subjects who
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 informationANORO ELLIPTA (Umeclidinium Bromide/Vilanterol Inhalation Powder) For Treatment of Chronic Obstructive Pulmonary Disease NDA
GlaxoSmithKline Inc. 5 Moore Drive Research Triangle Park, NC 27709 ANORO ELLIPTA (Umeclidinium Bromide/Vilanterol Inhalation Powder) For Treatment of Chronic Obstructive Pulmonary Disease NDA 203975 FDA
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 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 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 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 informationType of intervention Treatment. Economic study type Cost-effectiveness analysis.
Cost-effectiveness of salmeterol/fluticasone propionate combination product 50/250 micro g twice daily and budesonide 800 micro g twice daily in the treatment of adults and adolescents with asthma Lundback
More informationOutcomes: Initially, our primary definitions of pneumonia was severe pneumonia, where the subject was hospitalized
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:
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 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 informationStudy No.: LOV Title: Rationale: Phase: IIB Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary-
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 informationClinical Trial Results Summary Study EN3409-BUP-305
Title of Study: A 52-Week, Open-Label, Long-Term Treatment Evaluation of the Safety and Efficacy of BEMA Buprenorphine in Subjects with Moderate to Severe Chronic Pain Coordinating Investigator: Martin
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 informationNot available 100/6mcg 2 BD formoterol (Fostair MDI) 100/6mcg 33
COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP FLUTICASONE FUROATE/VILANTEROL COMBINATION INHALER - ASTHMA Policy agreed by Vale of York CCG (date) Drug, Treatment, Device name Fluticasone
More informationWhat is the current cost of COPD (Chronic Obstructive Pulmonary Disease) therapies?
What is the current cost of COPD (Chronic Obstructive Pulmonary Disease) therapies? Medicines in the COPD Ellipta portfolio are highlighted in orange on the graph below: Incruse Ellipta (umeclidinium)
More informationSponsor Novartis. Generic Drug Name. NA (not existing yet) Therapeutic Area of Trial Parkinson s Disease L-dopa induced dyskinesia
Page 1 Sponsor Novartis Generic Drug Name NA (not existing yet) Therapeutic Area of Trial Parkinson s Disease L-dopa induced dyskinesia Approved Indication Investigational. Study Number CA2206 Title A
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: 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 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: 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 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 informationSubjects from the Safety Population who had GSK PK parameter estimates from any portion of the study. Cohort 1 (N=8)
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 informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
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 informationStudy No.: 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 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 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: 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 informationRelvar Ellipta (fluticasone furoate and vilanterol as trifenatate) for the treatment of patients with COPD
Relvar Ellipta (fluticasone furoate and vilanterol as trifenatate) for the treatment of patients with COPD Medicines evidence pack to support formulary and guidelines decision making Prescribing information
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 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 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 information