Clinical trial NCT01012739: Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
Official title: A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
QAB149
indacaterol
pulmonary function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed description: This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

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.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment
timeFrame: Baseline and Day 1
Secondary outcomes:
measure: Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
timeFrame: Baseline and Day 1
measure: Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
timeFrame: From 5 minutes to 12 hours post-dose
measure: 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
timeFrame: From 5 minutes to 4 hours post-dose for each treatment
measure: Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment
timeFrame: 0 to 24 hours post-dose
measure: Indacaterol Exposure (Cmax) for Each Treatment
timeFrame: 0 to 24 hours post-dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: