CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
indacaterol maleate/mometasone furoate +2 moredrug
Likely dose
indacaterol maleate/mometasone furoate 250 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/NCT00556673
NCT00556673Phase 2Completed
CompareCT.gov

An Exploratory, Multi-centre, Double-blind, Placebocontrolled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler®) in Adult Patients With Persistent Asthma Using Open Label Seretide® Accuhaler® (50/250 Mcg b.i.d.) as an Active Control

Novartis·interventional·Posted Nov 12, 2007·Updated Apr 22, 2013

In Brief

A Phase 2 clinical trial evaluating indacaterol maleate/mometasone furoate, placebo to indacaterol maleate/mometasone furoate, and 1 other intervention for Asthma. Completed, enrolled 31 participants across 2 sites in 2 countries.

Detailed Summary

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance, Germany
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.6 years ago

Interventions

indacaterol maleate/mometasone furoatedrug

Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.

placebo to indacaterol maleate/mometasone furoatedrug

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

fluticasone proprionate / salmeterol xinafoatedrug

Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.