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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

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ClinicalTrials.gov Identifier: NCT01658891
Recruitment Status : Withdrawn
First Posted : August 7, 2012
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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

Condition or disease Intervention/treatment Phase
Asthma in Children Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg Drug: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 NEXThaler® (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 Start Date : February 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: CHF 1535 50/6 µg Drug: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks

Active Comparator: beclomethasone dipropionate 100µg + Formoterol fumarate 6µg 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




Primary Outcome Measures :
  1. Lower Leg Growth rate measured by Knemometry [ Time Frame: after 2 weeks of treatment ]

Secondary Outcome Measures :
  1. 24-hour urinary free cortisol/creatinine levels [ Time Frame: after 2 weeks of treatment ]
  2. Changes in pre-dose morning and evening PEF (L/min) [ Time Frame: after 2 weeks of treatment ]


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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658891


Locations
Denmark
BørneAstmaKlinikken
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01658891     History of Changes
Other Study ID Numbers: CCD-1110-PR-0071
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Formoterol Fumarate
Beclomethasone
Hydrocortisone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists