At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 173 enrolled

Drug / intervention

Indacaterol +2 moredrug

Likely dose

Indacaterol 150µgfrom 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/NCT01012765

NCT01012765Phase 3Completed

Compare CT.gov

A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control

Novartis Pharmaceuticals·interventional·Posted Nov 13, 2009·Updated Feb 17, 2016

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Tiotropium, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 173 participants across 21 sites.

Detailed Summary

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Obstructive Pulmonary Disease

CountriesGermany

Collaborators--

Timeline

Phase 3CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2009

First PostedNov 2009

Primary CompletionJan 2011

TodayJul 2026

First PostedNov 13, 2009

Enrollment StartNov 1, 2009

Primary CompletionJan 1, 2011

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 16.6 years ago

Interventions

Indacateroldrug

Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)

Tiotropiumdrug

Tiotropium 18µg o.d. delivered via a proprietary inhalation device.

Placebodrug

Placebo to indacaterol o.d. delivered via SDDPI