CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 657 enrolled
Drug / intervention
NVA237 +4 moredrug
Likely dose
NVA237 50 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/NCT01613326
NCT01613326Phase 3Completed
CompareCT.gov

A 12-week Treatment, Randomized, Blinded, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of NVA237 (50 µg o.d.) Compared to Tiotropium (18 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis Pharmaceuticals·interventional·Posted Jun 7, 2012·Updated Apr 23, 2014

In Brief

A Phase 3 clinical trial evaluating NVA237, Tiotropium, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 657 participants across 77 sites in 15 countries.

Detailed Summary

This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesCanada, Croatia, Czechia, Estonia, France, Germany, Guatemala, India, Latvia, Lithuania, Philippines, Poland, South Africa, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.1 years ago

Interventions

NVA237drug

NVA237 50 μg inhalation capsules once a day, delivered via SDDPI

Tiotropiumdrug

Tiotropium 18 μg once a day delivered via HandiHaler® device

Placebo to tiotropiumdrug

Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.

Placebo to NVA237drug

Placebo to NVA237 50 μg once a day delivered via SDDPI

salbutamol/albuteroldrug

salbutamol/albuterol given as a rescue medication via inhaler when needed