Phase 2
N=35
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01012739 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment — 2.97; 2.93; 2.91; 2.77 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Indacaterol 150 μg via the Concept1 dry-powder inhaler (Drug); Indacaterol 60 μg via the Simoon dry-powder inhaler (Drug); Indacaterol 120 μg via the Simoon dry-powder inhaler (Drug); Placebo to indacaterol via the Concept1 dry-powder inhaler (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment |
2.97; 2.93; 2.91; 2.77 | — |
| SECONDARY Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment |
3.19; 3.15; 3.15; 2.96 | — |
| SECONDARY Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment |
6.80; 8.22; 7.50; 7.93 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment |
3.03; 2.96; 2.99; 2.78 | — |
| SECONDARY Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment |
1119.2; 435.8; 849.4 | — |
| SECONDARY Indacaterol Exposure (Cmax) for Each Treatment |
150.5; 95.2; 141.7 | — |
Summary
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).
Eligibility Criteria
Inclusion criteria
- Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%
- Patients using inhaled corticosteroid (with or without long-acting beta agonist)
Exclusion criteria
- Asthma exacerbations in previous 6 months
- Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
- Excessive use of short-acting beta agonists
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT01012739). 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.