CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Glycopyrronium +3 moredrug
Likely dose
Not stated in 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/NCT01959516
NCT01959516Phase 4Completed
CompareCT.gov

Multicenter, Randomized, Blinded, Two-period Cross-over Study to Assess the Effect of Glycopyrronium (44 Micrograms QD) Versus Tiotropium (18 Micrograms QD) on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

Novartis Pharmaceuticals·interventional·Posted Oct 10, 2013·Updated Apr 15, 2016

In Brief

A Phase 4 clinical trial evaluating Glycopyrronium, Tiotropium, and 2 other interventions for COPD. Completed, enrolled 124 participants across 21 sites in 4 countries.

Detailed Summary

This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesGermany, Italy, Spain, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartFeb 1, 2014
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.7 years ago

Interventions

Glycopyrroniumdrug

Glycopyrronium capsule for inhalation once per day via SDDPI

Tiotropiumdrug

Tiotropium capsule for inhalation once per day via HandiHaler® device

Placebo to glycopyrroniumdrug

Placebo to glycopyrronium capsule for inhalation once per day via SDDPI

Placebo to tiotropiumdrug

Placebo to tiotropium capsule for inhalation once per day via HandiHaler® device