NCT02502734

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

Completed Phase 3 Results posted Last updated 17 November 2017

What this trial tests

Phase 3 trial testing Fluticasone furoate in Asthma in 60 participants. Completed in 21 December 2015.

Timeline

7 September 2015

Primary endpoint
21 December 2015

21 December 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	7 September 2015
Primary completion	21 December 2015
Estimated completion	21 December 2015
Sites	1 location across Denmark

Drugs / interventions tested

• Fluticasone furoate (FLUTICASONE FUROATE) — full drug profile →
• Placebo
• Salbutamol (salbutamol) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 5 to 11, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry. Primary · Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.

Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medi

Group	Value	95% CI
Placebo	0.3638	± 0.02793
Fluticasone Furoate	0.3118	± 0.02793

Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE). Secondary · From the start of study treatment until follow-up (assessed up to 54 days)

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were tre

Group	Value	95% CI
Placebo	15
Fluticasone Furoate	7

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/60 (2%)

Deaths: —

Fluticasone Furoate

Serious: 0/58 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Placebo	Fluticasone Furoate
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Placebo	Fluticasone Furoate
Headache	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—

Most-reported serious reactions: Asthma.

Data from ClinicalTrials.gov NCT02502734 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Packaging and Delivery of Asthma Therapeutics.
   Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092
2. Knemometry Assessment of Short-term Growth in Children With Asthma Receiving Fluticasone Furoate for 2 Weeks: A Randomized, Placebo-controlled, Crossover Trial.
   Wolthers OD, Stone S, Bareille P, Tomkins S, et al · · 2017 · cited 2× · PMID 28545804 · DOI 10.1016/j.clinthera.2017.04.011