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To Investigate the Effects of Altering the Time of Day of Dosing (Morning or Evening) With Fluticasone Furoate 100 Micrograms Once Daily Administered Via a Dry Powder Inhaler in Subjects With Asthma

NCT01808339 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-01-09

Study results available
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Summary

This study will investigate the effects of altering the time of day of dosing (morning or evening) with Fluticasone Furoate 100 (FF 100) micrograms (mcg) once daily administered via a dry powder inhaler (DPI) in subjects with persistent bronchial asthma. This is a repeat-dose, double-blind, randomized, placebo-controlled, three-way crossover study to compare the effect of morning (AM) and evening (PM) dosing with FF 100 on lung function. Twenty-four male and female subjects with persistent bronchial asthma will be enrolled to ensure twenty evaluable subjects. The three treatments will be FF 100 AM (with placebo PM), FF 100 PM (with placebo AM) and matching placebo (AM and PM). All treatments will be administered for 14 (+/-2) days with 14 day run-in and 14 to 21 day washout periods. The total duration of the study will be approximately 13 to18 weeks for each subject.

Conditions

Interventions

DRUG

Fluticasone Furoate (FF)

Inhalation powder 100 microgram per blister strip to be administered via dry powder inhaler either in the morning (AM dose with FF and PM dose with +/-2 days).

DRUG

Placebo

Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT01808339 on ClinicalTrials.gov