Completed

A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma

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What is being tested

QVM149 150/50/80 μg o.d.

+ QVM149 150/50/160 μg o.d.

+ salmeterol/fluticasone FDC 50/500 μg b.i.d.

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

From 18 to 75 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2017
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 21, 2017

Actual date on which the first participant was enrolled.

The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.

Official TitleA Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
NCT03063086
Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

17 exclusion criteria prevent from participating
Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1
Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention
Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
A-B-C

Group II

Active Comparator
A-C-B

Group III

Active Comparator
B-C-A

Group IV

Active Comparator
B-A-C

Group 5

Active Comparator
C-A-B

Group 6

Active Comparator
C-B-A

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

Novartis Investigative Site

Großhansdorf, GermanyOpen Novartis Investigative Site in Google Maps
Suspended

Novartis Investigative Site

Hanover, Germany
Suspended

Novartis Investigative Site

Sofia, Bulgaria
Suspended

Novartis Investigative Site

Changchun, China
Completed12 Study Centers