Knemometry Study to Compare the Systemic Safety of Flutiform pMDI, Fluticasone pMDI and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years.

Phase 2

Completed

• Conditions: Mild Persistent Asthma
• Interventions: Drug: Flutiform 50/5 ug (2 puffs bid) pMDI; Drug: Fluticasone 50 ug (2puffs bid) pMDI; Drug: Beclometasone Autohaler 50 ug (2 puffs bid)

• Registration Number: NCT02063139
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2014-06
• Study Completion: 2015-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flutiform 50/5 ug (2 puffs bid) pMDI	Flutiform 50/5 ug (2 puffs bid) pMDI	Flutiform 50/5 ug (2 puffs bid) pMDI
Fluticasone 50 ug (2puffs bid) pMDI	Fluticasone 50 ug (2puffs bid) pMDI	Fluticasone 50 ug (2puffs bid) pMDI
Beclometasone Autohaler 50 ug (2 puffs bid)	Beclometasone Autohaler 50 ug (2 puffs bid)	Active control

Primary Outcome Measures

Name	Time	Method
To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.	Change from baseline in growth rate during the each treatment and washout period which is 2 weeks	Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).

Secondary Outcome Measures

Name	Time	Method
To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg based on overnight urinary free cortisol (corrected for creatinine).	every two weeks for duration of study which is two months.	Subjects will empty their bladder into the toilet before going to bed at night (or no later than at 10pm). This urine will not be collected. This voiding time will be recorded as the start time of the urine collection. Urine passed after this time during the night (if any) and until 8 am in the morning will be collected into a clean container. Subjects will empty their bladders a final time at 8 am in to the container. This voiding time will be recorded as the stop time of the urine collection.

Trial Locations

Locations (1)

Asthma and Allergy Children's Clinic; 🇩🇰 Randers, Denmark