Double-blind comparison of inspiratory capacity (IC) and FEV1 in COPD patients following single dose administration of indacaterol and placebo and open-label b.i.d. administration of formoterol

Phase 1

• Conditions: COPD; MedDRA version: 8.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2006-003634-15-GB
• Lead Sponsor: ovartisPharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male and post-menopausal female adults aged 40-80 years inclusive.
2. Patients with a clinical diagnosis of COPD according to the GOLD Guidelines (2005)
3. Smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
4. Post-bronchodilator FEV1 at screening = 40% of the predicted normal value and = 1.0 L.
5. Post-bronchodilator FEV1/FVC < 70%
6. Reversibility to 400 µg salbutamol/albuterol = 5%. This criterion for reversibility must be demonstrated after a washout period of at least 6 h during which no short-acting b2-agonist has been inhaled, 48 h for long-acting b2-agonists and 72 h for anti-cholinergic agents
7. Able to perform reproducible spirometry maneuvers.
8. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. COPD exacerbations within 6 weeks prior to dosing
2. Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
3. Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
4. Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
5. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified