Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on October 19, 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):
E. Derom, Professor, Principal Investigator, Affiliation: State University, Ghent, Belgium
Summary
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Clinical Details
Official title:
Comparison of Inhaled Ciclesonide (160 Mcg b.i.d. or 320 Mcg b.i.d.) and Fluticasone Propionate (250 Mcg b.i.d. or 500 Mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: AUC(0-24h)/24 h of serum cortisol level24 h urinary cortisol excretion adjusted for creatinine.
Secondary outcome: 8 am measurement of bone formation markersPC20FEV1 to methacholine PC20FEV1 to AMP lung function (FEV1, FVC) pharmacokinetics safety and tolerability.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Main Inclusion Criteria:
- Patients who have had a history of bronchial asthma for at least 6 months
- FEV1 >60% of predicted for at least 24 h
- Patients who are hyperresponsive to methacholine and to AMP
- Patients who are in good health with the exception of asthma
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Patients suffering from COPD and/or other relevant lung diseases except asthma
- Current smokers and ex-smokers both with ≥10 pack years
Locations and Contacts
ALTANA Pharma, Cities in Belgium, Belgium
Additional Information
Starting date:
March 2003
Last updated: December 15, 2006
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