Comparison of the effect of Ipratropium Bromide Hydrofluoroalkane of Sun Pharmaceutical Industries Ltd, India and Atrovent® Hydrofluoroalkane of Boehringer Ingelheim Pharmaceuticals, Inc. on respiratory function in Subjects with Chronic Obstructive Pulmonary Disease
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2019/01/017133
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
1.    Men or non-pregnant and non-lactating women aged greater than or equal to 40 years.
2.    Diagnosis of COPD as defined by American Thoracic Society (ATS) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2017 (patient with dyspnea, chronic cough or sputum production, and/or history of exposure to risk factors for the disease).
3.    Post-bronchodilator FEV1 between 30-65% predicted (both inclusive) [criterion evaluated 24 to 72 hours prior to dosing in Period 1].
4.    Post-bronchodilator FEV1/FVC ratio less than or equal to 0.70 [criterion evaluated 24 to 72 hours prior to dosing in Period 1].
5.    Able to successfully complete placebo run-in after withholding restricted medications and able to restrict medications not permitted within 6 hours prior to dosing.
6.    Current or former smoker with smoking history of greater than or equal to 10 pack-years.
7.    Able to satisfactorily administer the medication and perform pulmonary function test.
8.    Willing and able to give written informed consent.
9.    Subjects of childbearing potential must practice an acceptable method of birth control as judged by the Investigator:
a.   Medically acceptable methods of birth control include the use of either a contraceptive implant or a contraceptive injection (e.g., Depo-Provera•) or an intra-uterine device, same sex partner, a vasectomized partner, or an oral contraceptive taken continually within the past 3 months and the subject has to agree to continued use during the study.
b.   To adopt another birth control method, or a double-barrier method which consists of a combination of any 2 of the following: diaphragm, cervical cap, condom, or a spermicide at least 2 months prior to study entry and must continue to use contraception for the duration of the study.
c. Subjects who are postmenopausal for at least 1 year (absence of menses for at least one year; a Follicular Stimulating Hormone (FSH) test may be performed to confirm menopause if the duration is less than one year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
1.      Subjects with evidence or history of significant disease or abnormality other than COPD (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infraction, stroke, glaucoma, or cardiac dysrhythmia). A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study, or the subjectâ??s ability to participate in the study.
2.      Known respiratory disorder other than COPD, including but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, significant asthma, sarcoidosis, lung fibrosis, pulmonary hypertension, or interstitial lung disease.
3.      History of allergy or hypersensitivity to anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, or specific intolerance to aerosolized ipratropium bromide-containing products, or known hypersensitivity to any of the non-medicinal ingredients [citric acid, ethanol, propellant HFA 134a (1,1,1,2-tetrafluorethane), nitrogen].
4.      History of asthma, allergic rhinitis, or atopy, a blood eosinophil count greater than 6%.
5.      Known active tuberculosis based on chest X-ray, physical examination and medical judgment of the investigator.
6.      Positive test results for Hepatitis B virus Surface Antigen (HBsAg), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
7.      History of having undergone thoracotomy with pulmonary resection. Subjects with a history or a thoracotomy for other reasons will be evaluated per exclusion criterion No. 1.
8.      History of narrow angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which, in the investigatorâ??s opinion, would contraindicate the use of an anticholinergic agent.
9.     Acute (viral or bacterial) upper or lower respiratory tract infection or illness within 6 weeks prior to dosing in period 1.
10.   Treatment for COPD exacerbation within 12 weeks prior to dosing in period 1.
11.   Hospitalization for COPD or pneumonia within 12 weeks prior to dosing in period 1.
12.   Lung volume reduction surgery within 12 months prior to dosing in period 1.
13.   Chronic oxygen use for greater than 12 hours/ day within12 weeks prior to dosing in period 1.
14.   Subjects on cromolyn sodium or nedocromil sodium within 6 weeks prior to dosing in period 1.
15.   Subjects on antihistamines within 4 weeks prior to dosing in period 1.
16.   Subjects with clinically significant lab abnormalities during screening as per medical judgment of the investigator.
17.   Participation in another clinical study within thirty (30) days prior to dosing in period 1.
18.   Subjects with a history of and/or active alcohol or drug abuse based on history and screening urine drug of abuse test.
19.   Subjects with a history of cancer within 5 years prior to study. Subjects with treated basal cell carcinoma are allowed.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Forced Expiratory Volume in One Second <br/ ><br>2. Area under the serial Forced Expiratory Volume in One Second-time curveTimepoint: 1.Forced Expiratory Volume in One Second: measured at 0 (within 15 minutes prior to <br/ ><br>dosing), 10, 15, 30, 60, 90 and 120 minutes, and 3, 4, 5, 6 and 7 hours post-dose. <br/ ><br>2. Area under the serial FEV1-time curve: measured from time 0 to 6 hours following the treatment.
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil