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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma

NCT02554786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2216

Last updated 2020-03-05

Study results available
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Summary

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control

Conditions

Interventions

DRUG

Indacaterol acetate/Mometasone furoate

DRUG

Mometasone furoate

DRUG

Salmeterol xinafoate/fluticasone propionate

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-29
Primary Completion
2018-11-21
Completion
2019-06-28
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • China
  • Croatia
  • Czechia
  • Egypt
  • Estonia
  • Germany
  • Guatemala
  • Hungary
  • India
  • Ireland
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • 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 NCT02554786 on ClinicalTrials.gov