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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

NCT ID: NCT01450774

Last Updated: 2017-03-29

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Childhood Asthma

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 50/6µg

Group Type EXPERIMENTAL

CHF 1535 50/6µg

Intervention Type DRUG

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

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Group Type ACTIVE_COMPARATOR

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

Intervention Type DRUG

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

Interventions

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CHF 1535 50/6µg

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

Intervention Type DRUG

beclomethasone dipropionate 50µg + formoterol fumarate 6µg

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hans Bisgaard, MD

Role: PRINCIPAL_INVESTIGATOR

BørneAstmaKlinikken

Locations

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BørneAstmaKlinikken

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/search?query=2010-023637-29

Study Record on EU Clinical Trials Register including results

Other Identifiers

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CCD-1012-PR-0051

Identifier Type: -

Identifier Source: org_study_id

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