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Phase 3 Completed N=511 Randomized Quadruple-blind Treatment

Efficacy and Safety of Different Doses of Indacaterol

Source: ClinicalTrials.gov NCT01079130 ↗
Enrolled (actual)
511
Serious AEs
0.2%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment — 2.50; 2.52; 2.59; 2.54 Liters

Summary

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

Outcome Measures

OutcomeResultp-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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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