At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 773 enrolled

Drug / intervention

NVA237 50µg once daily +3 moredrug

Likely dose

NVA237 50µg once dailyfrom 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/NCT01513460

NCT01513460Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals·interventional·Posted Jan 20, 2012·Updated Jan 5, 2015

In Brief

A Phase 3 clinical trial evaluating NVA237 50µg once daily, Tiotropium 18µg once daily, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 773 participants across 71 sites in 2 countries.

Detailed Summary

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Obstructive Pulmonary Disease

CountriesAustralia, New Zealand

Collaborators--

Timeline

Phase 3CompletedFinished

201220132014201520162017201820192020202120222023202420252026

First PostedJan 2012

Enrollment StartApr 2012

Primary CompletionDec 2013

TodayJul 2026

First PostedJan 20, 2012

Enrollment StartApr 1, 2012

Primary CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 14.5 years ago

Interventions

NVA237 50µg once dailydrug

NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)

Tiotropium 18µg once dailydrug

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

Flu/Saldrug

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

NVA237 placebo + Tiotropium placebo.drug

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