Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00546520

BY9010/M1-125

Details and patient eligibility

About

Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Enrollment

21 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria:

Out-patients
Written informed consent
History of atopic disease
History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
FEV1 ≥ 70% predicted
Hyperreactivity to AMP (PC20FEV1 < 25 mg/ml)
Good health with the exception of asthma
Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Main exclusion criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
Immunotherapy within one month prior to B0 and/or during the entire study duration