NCT02063139

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.

A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mild Persistent Asthma

Interventions

Type	Name	Description
DRUG	Flutiform 50/5 ug (2 puffs bid) pMDI
DRUG	Fluticasone 50 ug (2puffs bid) pMDI
DRUG	Beclometasone Autohaler 50 ug (2 puffs bid)

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-06-01
• Completion: 2015-01-01
• First posted: 2014-02-14
• Last updated: 2018-10-24

Locations

1 site across 1 country: Denmark