A clinical trial to compare the efficacy and safety of two formulations of inhaled ipratropium bromide in patients chronic obstructive pulmonary disease (COPD).
- Conditions
- Health Condition 1: null- CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
- Registration Number
- CTRI/2015/05/005793
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 395
COPD patients diagnosed according to GOLD criteria. Male or female subjects between 40-75 years of age inclusive. Pre bronchodilator FEV1 ï?³ 50% and <= 80% of predicted value. FEV1/FVC ratio pre-bronchodilator < 70% at screening. Smoking history of ï?³ 10 pack years. Patients must be able to effectively use the pMDI without a spacer . Subject or subjectâ??s legally acceptable representative is willing to sign informed consent document after the subject is provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug. COPD patients who require regular treatment with ipratropium bromide and who are treated with ipratropium bromide with or without β2-agonist inhalation.
Subjects with a history of asthma, allergic rhinitis, atopy or those who have a total eosinophil count greater than 600/µL . Acute exacerbation requiring hospitalization or Emergency Department treatment or as judged by the investigator or any change in COPD therapy (other than inhalation of short-acting β2-agonists as relief medication), within the last 3 months of the screening visit. Use of systemic corticosteroids within the last 3 months of the screening visit . Subjects suffering from any serious uncontrolled medical conditions or any concomitant pulmonary disease. Clinically relevant respiratory infection requiring antibiotics, as judged by the investigator, within the last 3 months prior to the screening visit. Females who are pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FEV1 at 90 min post dose on day 85Timepoint: Pre dose and at 90 minutes post dose
- Secondary Outcome Measures
Name Time Method Overall symptom scores <br/ ><br> <br/ ><br>Total daily use of inhaled rescue medication <br/ ><br> <br/ ><br>Timepoint: Baseline and after 4,8 and 12 weeks after randomisation