Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Inhaler (Fluticasone Furoate 100 microgram and Vilanterol 25 mcg): Inhaler Fluticasone Furoate 100 microgram and Vilanterol 25 mcg to be taken one puff once daily for a 12 week period.
Sponsors
Dr Raja Dhar
Eligibility
Inclusion criteria
Inclusion criteria: a) Adult male and female subjects between the ages of 35-55 and BMI less than 30 kg/m2 and having all the following: b) Smoking history >10 pack years (Or equivalent biomass fuel/environmental exposure – exposure to biomass fuel smoke while cooking - 2 hours a day for at least 13 years). c) Post Bronchodilator (400mcg Salbutamol by inhaled route) FEV1/FVC ratio > 0.70 d) COPD Assessment Test (CAT) score > 10 e) Respiratory Elastance (Ax) > 6 measured using Tremoflo.
Exclusion criteria
Exclusion criteria: a) Previous diagnosis of COPD or asthma b) History suggestive of asthma (symptom onset c) Known case of Glaucoma d) Known case of enlarge prostrate with symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CAT score from baseline to 12 weeks Change in AX & R520 from baseline to 12 weeks Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| a) FEV1/FVC b) FEF50 & 75 c) Minimal clinically significant change in Oscillometry Parameters that correlates with improvement in CAT score by 2. d) Exacerbations e) Rescue medication use f) Correlation between i) Blood eosinophil count and CAT score changes ii) Blood eosinophil count and Oscillometry changes iii) CAT score and Oscillometry g) Metabolomics that predict high CAT score and abnormal Oscillometry parameters. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Raja Dhar
The Calcutta Medical Research Institute
Outcome results
None listed