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A Study to Assess the Bronchodilator Effect of a Single Dose of Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 Micrograms (mcg) Combination When Administered in Adult Patients With Asthma

NCT01837316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-09

No results posted yet for this study

Summary

The study will be a randomized, double-blind, placebo controlled cross-over study in 32 adult subjects with moderately severe asthma. In this study the bronchodilator effect of a single morning dosing of FF/VI combination 100/25 mcg will be determined by spirometry. After the screening the subject will be randomized and will be assigned to one of two treatment sequences (AB or BA, where A is placebo and B is FF/VI 100/25 mcg). Between the two treatment periods there will be a washout period of 7-14 days. A serial forced expiratory volume in one second (FEV1) measurements will be taken at 15, 30 minutes, 1, 2, 4, 12, 24, 36, 48, 60 and 72 hours post dose. Safety assessments will include vital signs, electrocardiograms (ECGs), adverse event (AE) monitoring and laboratory safety tests however, these will not constitute study endpoints. The results of the study will provide supporting information to prescribers on the bronchodilator effect of FF/VI over 72 hours.

Conditions

Interventions

DRUG

FF/VI 100/25 mcg

First strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister

DRUG

Placebo

First strip: Inhalation powder of lactose

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
2013-10-21
Primary Completion
2014-08-08
Completion
2014-08-08

Countries

  • New Zealand

Study Locations

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Entities

Drugs
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 NCT01837316 on ClinicalTrials.gov