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Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium

NCT03158311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1426

Last updated 2021-10-08

Study results available
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Summary

The purpose of this trial was to demonstrate that the efficacy of two treatment arms of the fixed-dose combination product QVM149 was non-inferior to the efficacy of the free combination arm of salmeterol/ fluticasone+ tiotropium in uncontrolled moderate to severe asthmatic patients.

The planned duration of treatment in this study was 24 weeks, followed up by a 7-day follow-up period.

Conditions

Interventions

DRUG

QVM149

Indacaterol acetate / glycopyrronium bromide / mometasone furoate

DRUG

Salmeterol/fluticasone plus tiotropium

Free triple arm of salmeterol / fluticasone plus tiotropium

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2019-07-12
Completion
2019-07-19

Countries

  • Argentina
  • Chile
  • Colombia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Mexico
  • Peru
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Vietnam

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 NCT03158311 on ClinicalTrials.gov