CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Indacaterol +1 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/NCT02418468
NCT02418468Phase 4Completed
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Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Novartis Pharmaceuticals·interventional·Posted Apr 16, 2015·Updated Jul 11, 2017

In Brief

A Phase 4 clinical trial evaluating Indacaterol and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: 1. Indacaterol 150ug or 2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesHong Kong
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 16, 2015
Enrollment StartApr 28, 2015
Primary CompletionApr 19, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.2 years ago

Interventions

Indacateroldrug

Indacaterol 150µg capsules for inhalation daily

Placebodrug

Matching placebo indacaterol capsules for inhalation daily