CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,389 enrolled
Drug / intervention
Glycopyrronium +6 moredrug
Likely dose
Glycopyrronium 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/NCT01985334
NCT01985334Phase 4Completed
CompareCT.gov

A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

Novartis Pharmaceuticals·interventional·Posted Nov 15, 2013·Updated Mar 19, 2019

In Brief

A Phase 4 clinical trial evaluating Glycopyrronium, SABA, and 5 other interventions for COPD. Completed, enrolled 4,389 participants across 542 sites in 23 countries.

Detailed Summary

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesAustria, Belgium, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Russia, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 15, 2013
Enrollment StartFeb 14, 2014
Primary CompletionApr 29, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.6 years ago

Interventions

Glycopyrroniumdrug

Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day

SABAdrug

Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy

LABAdrug

Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy

Indacaterol maleate and glycopyrronium bromidedrug

Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day

LAMAdrug

Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy

SAMAdrug

Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy

ICSdrug

Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy