CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 388 enrolled
Drug / intervention
NVA237 12.5 µg once daily +7 moredrug
Likely dose
NVA237 12.5 µg 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/NCT01119950
NCT01119950Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, 2-period, Cross-over Study to Assess the Efficacy and Safety of Differing Doses of NVA237 Administered Either Once Daily or Twice Daily, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Novartis Pharmaceuticals·interventional·Posted May 10, 2010·Updated Mar 23, 2015

In Brief

A Phase 2 clinical trial evaluating NVA237 12.5 µg once daily, NVA237 25.0 µg once daily, and 6 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 388 participants across 29 sites in 7 countries.

Detailed Summary

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBelgium, Germany, Hungary, Netherlands, Poland, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.1 years ago

Interventions

NVA237 12.5 µg once dailydrug

NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

NVA237 25.0 µg once dailydrug

NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

NVA237 12.5 µg twice dailydrug

NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

NVA237 50.0 µg once dailydrug

NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

NVA237 25.0 µg twice dailydrug

NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

NVA237 100.0 µg once dailydrug

NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

NVA237 50.0 µg twice dailydrug

NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

Placebo to NVA237 once dailydrug

Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.