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Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma

NCT02502734 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-17

Study results available
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Summary

This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above.

ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.

Conditions

Interventions

DRUG

Fluticasone furoate

FF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.

DRUG

Placebo

Placebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.

DRUG

Salbutamol

Salbutamol will be provided as a inhaler.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-07
Primary Completion
2015-12-21
Completion
2015-12-21

Countries

  • Denmark

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 NCT02502734 on ClinicalTrials.gov