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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-02-29

Brief Summary

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single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids

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Detailed Description

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Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 1535 50/6 µg

Group Type EXPERIMENTAL

combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Intervention Type DRUG

beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

Group Type ACTIVE_COMPARATOR

free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

Intervention Type DRUG

beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

Interventions

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combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg

beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

Intervention Type DRUG

free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg

beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Prepuberal male and female outpatients, ≥ 5 and \< 12 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;

Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No