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

Primary Purpose

Childhood Asthma

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
CHF 1535 50/6µg
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BørneAstmaKlinikken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF 1535 50/6µg

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Arm Description

Outcomes

Primary Outcome Measures

Lower leg growth rate measured by knemometry

Secondary Outcome Measures

24-hour urinary free cortisol/creatinine levels
Changes in pre-dose morning and evening PEF (L/min)

Full Information

First Posted
September 23, 2011
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01450774
Brief Title
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 1535 50/6µg
Arm Type
Experimental
Arm Title
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHF 1535 50/6µg
Intervention Description
fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention Type
Drug
Intervention Name(s)
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Intervention Description
free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Primary Outcome Measure Information:
Title
Lower leg growth rate measured by knemometry
Time Frame
after a 2 week treatment
Secondary Outcome Measure Information:
Title
24-hour urinary free cortisol/creatinine levels
Time Frame
after a 2 week treatment period
Title
Changes in pre-dose morning and evening PEF (L/min)
Time Frame
pre and after a 2 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Bisgaard, MD
Organizational Affiliation
BørneAstmaKlinikken
Official's Role
Principal Investigator
Facility Information:
Facility Name
BørneAstmaKlinikken
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-023637-29
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

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

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