CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
Indacaterol +5 moredrug
Likely dose
Salmeterol/fluticasone (50/500 μg)from 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/NCT00669617
NCT00669617Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls

Novartis·interventional·Posted Apr 30, 2008·Updated Sep 12, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Salmeterol/fluticasone (50/500 μg), and 4 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 89 participants across 17 sites in 4 countries.

Detailed Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBelgium, Germany, Hungary, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 30, 2008
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.2 years ago

Interventions

Indacateroldrug

Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)

Salmeterol/fluticasone (50/500 μg)drug

Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Salbutamol (200 µg)drug

Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).

Placebo to Indacateroldrug

Placebo to indacaterol delivered via SDDPI

Placebo to Salmeterol/fluticasonedrug

Placebo to salmeterol/fluticasone delivered via MDDPI

Placebo to salbutamoldrug

Placebo to salbutamol delivered via MDDPI