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Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

NCT03108027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-01-05

Study results available
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Summary

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.

Conditions

Interventions

DRUG

Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)

Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)

DRUG

Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)

QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)

DRUG

Treatment C: Placebo (morning dose) and placebo (evening dose)

Placebo (morning dose) and placebo (evening dose)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2018-02-24
Completion
2018-02-24

Countries

  • Germany
  • Netherlands
  • 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 NCT03108027 on ClinicalTrials.gov