None listed
Conditions
Brief summary
We are investigating the effect of Indacaterol on the effect on volatile organic compounds (VOCS) in COPD from exhaled air. VOCS would be initially sampled from healthy controls and COPD. The COPD patients would be randomised to treatment or placebo and VOCS measured. We would then determine whether there are specific VOCS in COPD that changes with treatment. Thsi would give us insights into biomarkers for this disease.
Interventions
Indacaterol 300micrograms daily for 10 days
We are not able to monitor adherence but will test changes in exhaled molecules on Indacaterol.
Indacaterol is an inhaler
Sponsors
Lung Institute of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
The people eligible for the study are patients with 1)COPD. based on the criteria described below. 2) Healthy controls with no COPD and within the same age range as subjects with COPD. 1. GOLD Criteria for severity of COPD a. Mild – FEV1/FVC< 70%, FEV1< 80% b. Moderate – FEV1/FVC< 70%, FEV1 50-80% 2. COPD chronic bronchitis or Emphysema 3. Age – 50-70 years 4. males and females
Exclusion criteria
1. Present smokers 2. Severe CCF 3. Liver, renal failure 4. Diabetes 5. On immunosuppressive drugs 6. Auto-immune conditions such RA 7. Vascular disease – Scleroderma , SLE 8. Any history of asthma 9. Exacerbations in the last 6 weeks 10. Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding 11. Known sensitivity to study drug(s) or class of study drug(s) 12. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
Outcome results
None listed