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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01658891
First received: August 3, 2012
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Lower Leg Growth rate measured by Knemometry [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 24-hour urinary free cortisol/creatinine levels [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Changes in pre-dose morning and evening PEF (L/min) [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658891

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

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01658891     History of Changes
Other Study ID Numbers: CCD-1110-PR-0071, 2011-004873-96
Study First Received: August 3, 2012
Last Updated: February 18, 2013
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on August 21, 2014