CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Indacaterol maleate 400 μg +3 moredrug
Likely dose
Indacaterol maleate 400 μgfrom 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/NCT00927901
NCT00927901Phase 2Completed
CompareCT.gov

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma

Novartis Pharmaceuticals·interventional·Posted Jun 25, 2009·Updated Sep 9, 2013

In Brief

A Phase 2 clinical trial evaluating Indacaterol maleate 400 μg, Indacaterol acetate 400 μg, and 2 other interventions for Asthma. Completed, enrolled 30 participants across 3 sites in 3 countries.

Detailed Summary

This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance, Germany, Italy
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2009
Enrollment StartJun 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.0 years ago

Interventions

Indacaterol maleate 400 μgdrug

Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.

Indacaterol acetate 400 μgdrug

Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.

Indacaterol xinafoate 400 μgdrug

Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.

Placebo to indacateroldrug

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