Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients with a diagnosis of asthma and:

• Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening

• FEV1 ≥50% and ≤90% of predicted normal at screening

• An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria:

• Smoking history of ≥ 10 years

• Patients with a diagnosis of COPD

• Patients who have been previously intubated for a severe asthma exacerbation/ attack

• Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening

• Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening

• Patients who have had a respiratory tract infection within 6 weeks prior to screening

• Patients with seasonal allergy whose asthma is likely to deteriorate during the study period

• Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply