Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

NCT02571777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3092

Last updated 2020-07-22

Study results available
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Summary

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

Conditions

Interventions

DRUG

QVM149 150/50/160

DRUG

QVM149 150/50/80

DRUG

QMF149 150/320

DRUG

QMF149 150/160

DRUG

salmeterol/fluticasone

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-08
Primary Completion
2019-06-14
Completion
2019-06-14

Countries

  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Latvia
  • Lebanon
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom
  • Vietnam

Study Locations

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Entities

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 NCT02571777 on ClinicalTrials.gov