Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:

• Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks

• Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value

• Patients who demonstrate an increase of >= 12% and 200 mL in FEV1

• ACQ-5 score ≥ 1.5

Exclusion Criteria:

• Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).

• Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.

• Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply