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Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT03162055 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1119

Last updated 2019-05-22

Study results available
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Summary

This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.

Conditions

  • Chronic Obstructive Pulmonary Disease COPD

Interventions

DRUG

Glycopyrronium/Formoterol Fumarate

Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation

DRUG

umeclidinium/vilanterol

Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation

Sponsors & Collaborators

  • Parexel International Ltd

    collaborator UNKNOWN

  • Cognizant Technology Solution

    collaborator UNKNOWN

  • CISCRP

    collaborator INDUSTRY

  • eResearchTechnology

    collaborator INDUSTRY

  • QuintilesIMS Limited

    collaborator UNKNOWN

  • Corporate Translations Inc

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2018-05-04
Completion
2018-05-04
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Hungary
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT03162055 on ClinicalTrials.gov