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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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00163371
First received: September 12, 2005
Last updated: November 30, 2016
Last verified: October 2016
  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 AstraZeneca:

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
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
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
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00163371     History of Changes
Other Study ID Numbers: BY9010/M1-208 
Study First Received: September 12, 2005
Last Updated: November 30, 2016
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on December 02, 2016