Phase 3
N=511
Efficacy and Safety of Different Doses of Indacaterol
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01079130 ↗Enrolled (actual)
511
Serious AEs
0.2%
Results posted
Aug 2011
Primary outcome: Primary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment — 2.50; 2.52; 2.59; 2.54 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indacaterol (Drug); Salmeterol (Drug); Placebo to Indacaterol (Drug); Placebo to Salmeterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment |
2.50; 2.52; 2.59; 2.54; 2.54; 2.42 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment |
2.46; 2.52; 2.54; 2.60; 2.65; 2.45 | — |
Summary
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol
Eligibility 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
- Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal
- 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
Data sourced from ClinicalTrials.gov (NCT01079130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.