Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male or female participants; Laboratory parameters including CBC, LFT, RFT within clinically acceptable ranges; Moderate to Heavy Smokers with post-bronchodilator FEV1 greater than 60% predicted and FEV1 and FVC ratio greater than 0.65; Resting SpO2 greater than 92 percent; Mild to moderate asthma or GOLD Stage 1 to 2 COPD; Subject with stable inhaled therapy; Chest X ray without significant abnormality
Exclusion criteria
Exclusion criteria: Severe or unstable asthma or COPD; Acute respiratory infection; Use of systemic corticosteroids or immunosuppressants; Current use of chronic oxygen therapy or NIV; Known chronic pulmonary disorders other than asthma or COPD; Significant cardiovascular, hepatic, renal, or other systemic disease; Pregnant or breastfeeding women; Participation in another clinical trial; Known allergy to product ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Lung Function score and Pulmonary Function parameters including FEV1, FVC, FEV1 and FVC ratioTimepoint: Lung Function Score will be assessed at Baseline, Day 30 and Day 60. Pulmonary Function parameters will be evaluated at Screening and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in arterial blood gas parameters including PaO2, PaCO2, and SaO2, C-reactive protein and IgE levels, chest X-ray findings, use of rescue medications, CBC, blood Glucose, LFT, Renal function, incidence and severity of adverse eventsTimepoint: Baseline to Day 60 | — |
Countries
India
Contacts
BIORADIAN LIFESCIENCE