CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 169 enrolled
Drug / intervention
Indacaterol +2 moredrug
Likely dose
Indacaterol 150 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/NCT00615459
NCT00615459Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control

Novartis·interventional·Posted Feb 14, 2008·Updated Aug 17, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Tiotropium, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 169 participants across 20 sites in 7 countries.

Detailed Summary

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesAustralia, Germany, Netherlands, New Zealand, Poland, South Africa, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.4 years ago

Interventions

Indacateroldrug

Indacaterol 150 μg or 300 μg, delivered via SDDPI

Tiotropiumdrug

Tiotropium 18 μg once daily delivered via inhalation device

Placebodrug

Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)