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1 Clinical Trial Details (PDF Generation Date :- Wed, 31 Oct :13:48 GMT) CTRI Number Last Modified On 17/01/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/01/ [Registered on: 20/01/2015] - Trial Registered Retrospectively Yes Interventional Drug Randomized, Parallel Group, Multiple Arm Trial To know the safety and efficacy of Antioxidants in Patients of chronic obstructive pulmonary disease. Comparative Evaluation of Efficacy and safety Profile of Antioxidants-N-Acetyl-L-Cysteine(NAC) and Superoxide Dismutase(SOD)Supplementation in Patients of COPD. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Designation Affiliation Details of Principal Investigator Dr Asif hussain Junior resident, department of pharmacology, jnmc, AMU JNMCH, AMU Phone Fax Designation Affiliation Department of pharmacology, JNMCH, AMU, ALIGARH asif14358@yahoo.com Details Contact Person (Scientific Query) Dr WASEEM RIZVI Associate Professor JNMCH, AMU Phone Fax Designation Affiliation Department of pharmacology, Jawaharlal Nehru Medical College, AMU, ALIGARH waseemnakhat@gmail.com Details Contact Person (Public Query) Dr Asif hussain Junior resident, department of pharmacology, jnmc, AMU JNMCH, AMU Phone Fax Department of pharmacology, JNMCH, AMU, ALIGARH page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria > JNMCH, AMU Type of Sponsor List of Countries of Principal Investigator Dr ASIF HUSSAIN asif14358@yahoo.com Source of Monetary or Material Support Primary Sponsor Details Jawaharlal Nehru Medical College and Hospital Muslim University Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital,AMU ALIGARH UP Government medical college of Site Site Phone/Fax/ Departments of Pharmacology & Tuberculosis and Respiratory diseases J.N.Medical College, A.M.U,ALIGARH asif14358@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional ethics committee Status Not Applicable Health Type Patients Approved 25/03/2014 No Date No Date Specified Condition Chronic obstructive pulmonary disease (COPD) Type Details Comparator Agent Control Group Patients on standard therapy only for 12 weeks Intervention SOD Group Patients on standard therapy + oral Superoxide Dismutase(SOD) 1 tab OD (140 I.U)for 12 weeks Intervention NAC Group Patients on standard therapy + oral N-acetyl-L-cysteine(NAC) 600 mg OD for 12 weeks Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Patients of COPD, diagnosed clinically and spirometrically. 2.Having complaints of breathlessness, tightness in chest, cough with or without sputum. 3.Cases of Grade I to III COPD as per GOLD guidelines. Exclusion Criteria Details Exclusion Criteria 1.Complicated cases of chronic obstructive pulmonary disease with page 2 / 7

3 respiratory failure. 2.Patient with bronchial asthma. 3.Pregnant and lactating mothers. 4.Patients with clinically relevant, abnormal laboratory values suggesting an unknown disease requiring further investigation. 5.Psychotic patients 6.HIV/HBsAg/AntiHCV positive and immune compromised patients. Method of Generating Random Sequence Method of Concealment Blinding/Masking Random Number Table An Open list of random numbers Open Label Primary Outcome Outcome Timepoints PFT th week Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Haemogram with ESR Blood sugar E.C.G X-ray chest P/A view L.F.T. R.F.T. Total Sample Size=150 Sample Size from =150 01/05/2014 No Date Specified Years=1 Months=7 Days=0 Not Applicable Open to Recruitment th week INTRODUCTION Chronic obstructive pulmonary disease (COPD) is defined as a disease state characterized by airflow limitation that is not fully reversible page 3 / 7

4 COPD includes emphysema, an anatomically defined condition characterized by destruction and enlargement of the lung alveoli. Chronic bronchitis, a clinically defined condition with chronic cough and phlegm; and small airway disease,a condition in which small bronchioles are narrowed. COPD is the leading cause of death and affects >14 million persons in. COPD is also a disease of increasing public health importance around the world. Estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by RISK FACTORS FOR COPD 1. Cigarette Smoking 2. Airway Responsiveness 3. Respiratory Infections 4. Occupational Exposures PATHOPHYSIOLOGY [5] Airflow Obstruction: Airflow obstruction is typically determined by spirometry. Key parameters obtained from spirometry include FEV 1 and the total volume of air exhaled during the entire spirometric maneuver [forced vital capacity (FVC)]. Patients with airflow obstruction related to COPD have a chronically reduced ratio of FEV 1 /FVC. In contrast to asthma, the reduced FEV 1 in COPD seldom shows large responses to inhaled bronchodilators, although improvements up to 15% are common. Hyperinflation: There is often "air trapping" and progressive hyperinflation late in the disease. Hyperinflation of the thorax page 4 / 7

5 during tidal breathing preserves maximum expiratory airflow, because as lung volume increases, elastic recoil pressure increases, and airways enlarge so that airway resistance decreases. Gas Exchange: The Pa O2 usually remains near normal until the FEV 1 is decreased to ~50% of predicted, and even much lower FEV 1 values can be associated with a normal Pa O2, at least at rest. An elevation of arterial level of carbon dioxide (Pa CO2 ) is not expected until the FEV 1 is <25% of predicted. PATHOGENESIS Ø Chronic exposure to cigarette smoke may lead to inflammatory cell recruitment within the terminal air spaces of the lung. Ø These inflammatory cells release elastolytic proteinases that damage the extracellular matrix of the lung. Ø Structural cell death results from oxidative stress and loss of matrix-cell attachment. Ø Ineffective repair of elastin and other extracellular matrix components result in air space enlargement that defines pulmonary emphysema. SYMPTOMS The three most common symptoms in COPD are: Ø Cough Ø Sputum production, Ø Exertional dyspnea page 5 / 7

6 GOLD GRADING SYSTEM GOLD Spirometric Criteria for COPD Severity I. Mild COPD FEV 1 /FVC < 0.7 FEV 1?80% predicted At this stage, the patient is probabl unaware that lung function is startin decline II. Moderate COPD FEV 1 /FVC < 0.7 FEV 1 (50% -79%) predicted Symptoms during this stage progre with shortness of breath developing exertion. III. Severe COPD FEV 1 /FVC < 0.7 FEV 1 (30%-49%) predicted Shortness of breath becomes wors this stage and COPD exacerbation common. IV. Very Severe COPD FEV 1 /FVC < 0.7 Quality of life at this stage is gravel impaired. COPD exacerbations can FEV 1 < 30% predicted orlife threatening. FEV 1 < 50% predicted with chronic respiratory failure Drugs to be used in COPD patients 1. N-acetyl-L-cysteine(NAC) 600 mg BD 2. Superoxide dismutase(sod) 140 IU OD Variety of oxidants, free radicals and aldehydes are implicated in pathogenesis of COPD. Therapeutic administration of appropriate antioxidants will be effective in treatment of COPD cases. They neutralize the increased oxidative stress and a page 6 / 7

7 Powered by TCPDF ( PDF of Trial subsequent inflammatory response. Antioxidants such as thiol donors (GSH and mucolytic drugs such as N acetyl cysteine, carbocysteine, dietary polyphenols and flavonoids ) have all been reported to scavange /detoxify free radicals/oxidants.there are several studies with N-acetylcysteine(NAC) suggests a reduction in the number of exacerbations in patients having varying grades of COPD. Once daily formulation is well tolerated and is likely to improve patient s compliance with prescribed regimen. Till date there is no study where two compounds have been compared in COPD patients.so the present study is designed to compare the safety and efficacy of N-acetylcysteine and Superoxide dismutase in patients of mild to moderate COPD. page 7 / 7