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A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.

NCT02712047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-08-28

Study results available
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Summary

For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2 receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric oxide (FeNO) is a non-invasive airway inflammation marker.

In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose study, the duration of action of fluticasone furoate (FF) will be determined by monitoring the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in asthmatic subjects.

Subjects who meet the eligibility criteria will participate in the following two treatment periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be followed by a 21-day monitoring/washout period before crossing over to the next treatment period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).

Conditions

Interventions

DRUG

Fluticasone furoate (FF) (100 mcg)

First blister strip contains FF blended with lactose, 100 mcg per blister

DRUG

Vilanterol (VI) (25 mcg)

Second blister strip contains vilanterol blended with lactose and magnesium stearate, 25 mcg per blister

DRUG

Placebo

Matching placebo will have two blister strips, identical in appearance to the inhaler containing active study medication; one containing lactose and the second strip containing lactose and magnesium stearate

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2017-02-21
Completion
2017-02-21

Countries

  • New Zealand

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Entities

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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 NCT02712047 on ClinicalTrials.gov