To compare the efficacy and safety of IN-ALR-01 versus IN-ALR-01 with Tiotropium and IN-ALR-01 with Salmeterol in patients with moderate to severe COPD
- Conditions
- Health Condition 1: null- Moderate to Severe COPD
- Registration Number
- CTRI/2012/12/003177
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
• Age > than 40 yrs
• Smoker with a smoking history of at least ten pack-years
• Patient with moderate to severe COPD
• Stable clinical disease status with no change in COPD treatment during the 4 weeks before screening period
• Female patients of childbearing potential- if they are willing to use a medically valid and effective contraception throughout the study period
• Patients are willing to provide written informed consent
• Patients with asthma or other relevant active lung diseases (e.g., lung cancer, tuberculosis, bronchiectasis etc.)
• Patients on long-term oxygen treatment
• Recent exacerbation of COPD that required a course of systemic corticosteroids, emergency room treatment, or hospital admission (within 4 weeks before screening period)
• Serious cardiovascular diseases (uncontrolled hypertension, angina pectoris, myocardial infarction, etc.)
• History known alpha-1-antitrypsin deficiency
• Patients with Hepatic insufficiency (SGOT/SGPT _ 2.0 x ULN) or Renal insufficiency (serum creatinine _ 1.5 x ULN)
• Clinically significant abnormalities on physical examination or laboratory tests
• History of any neuropsychiatric illness or suicidal thoughts & tendency
• Pregnant, lactating / nursing women
• Patients having participated in any type of clinical study within in the last one month of the screening date
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean prebronchodilator FEV1 from baseline to each postrandomisation visit between treatment arms.Timepoint: Change in mean prebronchodilator FEV1 from baseline to each postrandomisation visit between treatment arms.
- Secondary Outcome Measures
Name Time Method â?¢Change in mean postbronchodilator FEV1 and FVC from baseline to each postrandomization visit. <br/ ><br>â?¢Rate of COPD exacerbations between treatment arms <br/ ><br>â?¢Use of rescue medicationsTimepoint: 24 WEEKS