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Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163371
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Condition Intervention Phase
Asthma
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Ciclesonide (320 Mcg/Day) vs Fluticasone Propionate (375 Mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • growth velocity of the right lower leg as measured by knemometry.

Secondary Outcome Measures:
  • HPA-axis function
  • weight and height
  • lung function from spirometry
  • asthma symptom score, use of rescue medication from diary
  • adverse events
  • vital signs, including blood pressure, pulse rate
  • physical examination
  • laboratory investigation.

Estimated Enrollment: 28
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
  • Prepubertal stage
  • Good health with the exception of asthma
  • History of asthma for at least 6 months
  • Currently using rescue medication only

Main Exclusion Criteria:

  • Childbearing potential (beyond menarche)
  • Concurrent diseases or conditions which may subsequently affect growth
  • COPD or relevant lung diseases causing alternating impairment in lung function
  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • History of life-threatening asthma
  • Current smoking
  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: NCT00163371

Locations
Denmark
Altana Pharma/Nycomed
Kolding, Denmark, 6000
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Søren Pedersen, Prof. University of Odense, Kolding, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163371     History of Changes
Other Study ID Numbers: BY9010/M1-208
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Takeda:
Asthma
Ciclesonide
Child
Fluticasone propionate
HPA-axis
Pediatric
Linear growth rate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Ciclesonide
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014