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)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Søren Pedersen, Prof., Principal Investigator, Affiliation: University of Odense, Kolding, Denmark
Summary
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.
Clinical Details
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
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: growth velocity of the right lower leg as measured by knemometry.
Secondary outcome: HPA-axis functionweight 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.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
ALTANA Pharma, Cities in Denmark, Denmark
Additional Information
Starting date:
September 2005
Last updated: December 15, 2006
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