Study to assess efficacy & safety of doxofylline 400 mg twice daily versus doxofylline 800 mg ER once daily in the treatment of chronic obstructive pulmonary disease.
- Registration Number
- CTRI/2008/091/000154
- Lead Sponsor
- German Remedies Division, Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Patients ³40 years, (male or non-pregnant female)
Clinical diagnosis of stable COPD
Patients with severe COPD requiring oxygen therapy, COPD exacerbation in the 4 weeks prior to screening visit or untreated serious respiratory infectious disease
History of hypersensitivity methylxanthines, doxofylline or any ingredients of study formulations
History of asthma, allergic rhinitis, atopy, or an elevated blood eosinophil count
Recent history of myocardial infarction, heart failure, or cardiac arrhythmia requiring treatment and uncontrolled hypertension, severe renal or hepatic disease, active peptic ulcer disease
Pregnant or breastfeeding females
Patients already part or being a part of any clinical study in previous 1 months
Any reasons at the discretion of investigators does not allow patients to participate in study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method