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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.

NCT02063139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-10-24

No results posted yet for this study

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

DRUG

Flutiform 50/5 ug (2 puffs bid) pMDI

DRUG

Fluticasone 50 ug (2puffs bid) pMDI

DRUG

Beclometasone Autohaler 50 ug (2 puffs bid)

Sponsors & Collaborators

  • Mundipharma Research Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-06-30
Completion
2015-01-31

Countries

  • Denmark

Study Locations

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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 NCT02063139 on ClinicalTrials.gov