CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
fluticasone propionate/salmeterol +3 moredrug
Likely dose
fluticasone propionate/salmeterol 50 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/NCT00557440
NCT00557440Phase 2Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF TWISTHALER Device in Adult Patients With Persistent Asthma

Novartis·interventional·Posted Nov 14, 2007·Updated Mar 21, 2013

In Brief

A Phase 2 clinical trial evaluating fluticasone propionate/salmeterol, indacaterol maleate / mometasone furoate, and 2 other interventions for Asthma. Completed, enrolled 37 participants across 6 sites in 2 countries.

Detailed Summary

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartNov 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.6 years ago

Interventions

fluticasone propionate/salmeteroldrug

Fluticasone propionate/salmeterol 250/50 μg twice daily delivered via MDDPI.

indacaterol maleate / mometasone furoatedrug

Indacaterol maleate / mometasone furoate 500/400 μg once daily delivered via the TWISTHALER device.

placebo to indacaterol/mometasonedrug

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

placebo to fluticasone propionate/salmeteroldrug

Placebo to fluticasone propionate / salmeterol delivered via MDDPI.