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NCT00163332 Clinical Trial

Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00163332
Other study ID # BY9010/M1-129
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated December 2, 2016
Start date March 2003

Study information
Verified date September 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministère fédéral des Affaires sociales, de la Santé publique et de l'Environnement
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ciclesonide

Locations
Country Name City State
Belgium Altana Pharma/Nycomed Genk
Belgium Altana Pharma/Nycomed Ghent
Belgium Altana Pharma/Nycomed Lanaken
Belgium Altana Pharma/Nycomed Liege
Belgium Altana Pharma/Nycomed Liége

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC(0-24h)/24 h of serum cortisol level
Primary 24 h urinary cortisol excretion adjusted for creatinine.
Secondary 8 am measurement of bone formation markers
Secondary PC20FEV1 to methacholine
Secondary PC20FEV1 to AMP
Secondary lung function (FEV1, FVC)
Secondary pharmacokinetics
Secondary safety and tolerability.
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