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Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

NCT01985334 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4389

Last updated 2019-03-19

Study results available
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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.

Conditions

Interventions

DRUG

Glycopyrronium

Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day

DRUG

SABA

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

DRUG

LABA

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

DRUG

Indacaterol maleate and glycopyrronium bromide

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

DRUG

LAMA

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

DRUG

SAMA

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

DRUG

ICS

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-14
Primary Completion
2016-04-29
Completion
2016-04-29

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01985334 on ClinicalTrials.gov