CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Indacaterol 150 μg via the Concept1 dry-powder inhaler +3 moredrug
Likely dose
Indacaterol 150 μg via the Concept1 dry-powder inhalerfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01012739
NCT01012739Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Nov 13, 2009·Updated Aug 29, 2011

In Brief

A Phase 2 clinical trial evaluating Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler, and 2 other interventions for Asthma. Completed, enrolled 35 participants across 4 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany, Netherlands, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.6 years ago

Interventions

Indacaterol 150 μg via the Concept1 dry-powder inhalerdrug

Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Indacaterol 60 μg via the Simoon dry-powder inhalerdrug

Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Indacaterol 120 μg via the Simoon dry-powder inhalerdrug

Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Placebo to indacaterol via the Concept1 dry-powder inhalerdrug

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.