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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163332

BY9010/M1-129

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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