Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Treatment with comparator agent and add on tadalafil: 10 mg a day to start with and gradually increase the dose to 20 mg a day and to continue.
Control Intervention1: Standard pharmacot
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: These patients shall have to be on optimal standard management of COPD/ in the underlying disease and the existing co-morbid conditions. Patients with 18 years to 75 years in both sexes. A proper written consent will be taken before including the patients in the study.
Exclusion criteria
Exclusion criteria: 1) Very sick patients. 2) Features of significant RV failure: clinical and echocardiographic (should be treated under admission and direct supervision). 3) LV systolic dysfunction. 4) Inability to perform 6 MWT/ 2-CT 5) Grossly oxygen dependence 6) Associated other diseases (remaining untreated) that can cause PH 7) History of exacerbation in the preceding 4 weeks of screening and 6 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome of the study is to determine the change in 6MWD in the patients over the study periodTimepoint: The primary outcome for each patient would be specifically assessed periodically at baseline, after 3 months, 6 months, 9 months and 12 months respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Preparation for exploratory research: To preserve serum and DNA for future research.Timepoint: 8 months (Total) 4 months for 1st year, 4 months for 2nd year. | — |
Countries
India
Contacts
Public ContactParthasarathi Bhattacharyya
Institute of Pulmocare and Research
Outcome results
None listed