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Completed

NCT Number: NCT01450774

Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.

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Key information

Conditions

Childhood Asthma

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BørneAstmaKlinikken

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
  • Clinical diagnosis of mild asthma during at least two months prior to screening visit
  • Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit

Exclusion criteria

  • Endocrinological diseases including growth impairment or other chronic diseases
  • Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids

Treatment and study plan

CHF 1535 50/6µg

Drug

fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Drug

free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Primary outcomes

  1. Lower leg growth rate measured by knemometry

    Time frame: after a 2 week treatment

Secondary outcomes

  1. 24-hour urinary free cortisol/creatinine levels

    Time frame: after a 2 week treatment period

  2. Changes in pre-dose morning and evening PEF (L/min)

    Time frame: pre and after a 2 week treatment period

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and the Free Combination of Licensed Beclomethasone Dipropionate and Formoterol Fumarate in Asthmatic Children Already Treated With Inhaled Corticosteroids

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 12, 2011
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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