Efficacy and Safety of Different Doses of Indacaterol

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

Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• Patients with a diagnosis of asthma, and:

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

2. Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal

3. An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol

Exclusion Criteria:

• Smoking history >10 pack-years

• Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)

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

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

• Patients who have had an intubation for a severe asthma exacerbation

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

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

• Patients with concomitant pulmonary disease

• Patients with diabetes Type I or uncontrolled diabetes Type II

• Any patient with lung cancer or a history of lung cancer

• Patients with a history of certain cardiovascular comorbid conditions

• Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy

Other protocol-defined inclusion/exclusion criteria may apply