At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 776 enrolled

Drug / intervention

NVA237 +2 moredrug

Likely dose

Salbutamol 100 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/NCT02371629

NCT02371629Phase 4Completed

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A Randomized, Double-blind, Parallel Group, 26-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 Given Once or Twice Daily, in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals·interventional·Posted Feb 25, 2015·Updated Aug 9, 2019

In Brief

A Phase 4 clinical trial evaluating NVA237, Placebo, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 776 participants across 81 sites in 10 countries.

Detailed Summary

This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChronic Obstructive Pulmonary Disease

CountriesBelgium, Bulgaria, Finland, Germany, Hungary, Israel, Poland, Romania, Russia, Sweden

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

First PostedFeb 2015

Enrollment StartJun 2015

Primary CompletionNov 2016

TodayJul 2026

First PostedFeb 25, 2015

Enrollment StartJun 24, 2015

Primary CompletionNov 16, 2016

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 11.4 years ago

Interventions

NVA237drug

NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1

Placebodrug

Placebo to NVA237

Salbutamoldrug

All patients received salbutamol (100 μg) as only rescue medication