None listed
Conditions
Interventions
The study is set up as a randomised, double-blind, dubbeldummy study in two parallel groups.
In period 1 (5 weeks) all the patients get an inhaler with Ventolin® which they can use during both study
Sponsors
ALTANA Pharma B.V, Hoofddorp, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Outpatients males or females; 3. Good health with the exception of asthma; 4. Age 18 up to and including 60 years; 5. History of bronchial asthma (according to GINA 2004); 6. FEV1 > 1.20L, measured at least 6 hours after the last use of rescue medication; 7. Atopy shown by positive skin prick test to common allergen (historic tests are accepted, if results are available and test was done within 3 years prior to visit B0); 8. Stable asthma (no exacerbation or relevant respiratory tract infection within 2 months prior to the study); 9. Patients who are steroid-naive or who have been pretreated with inhaled glucocorticosteroid of up to 500 µg/d fluticasone or equivalent alone or in combination with long-acting beta-agonists at a constant dosage for at least 28 days prior to visit B0.
Exclusion criteria
Exclusion criteria: The presence of any one of the following will cause exclusion of the patient: a. Diseases and health status: 1. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation; 2. Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment); 3. Suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function; 4. Hospitalization because of asthma during the previous 6 months prior to visit B0; 5. One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to visit B0; 6. Ex-smokers with > 10 pack years, or having smoked within 1 year prior to visit B0; 7. Current smokers; 8. Positive response to saline challenge at baseline visits B1, B2 or B3 (defined as 20% fall in FEV1); 9. PC20 > 160 mg/ml to AMP-ATS at B1; 10. FEV1 ≤ 1.20 l prior to each bronchial challenge test; b. Medications: 11. Use of systemic steroids within 4 weeks (injectable depot steroids 6 weeks) prior to visit B0 or more than 1 course during the last 6 months prior to visit B0; 12. Use of other drugs not allowed (see 7.4); 13. Washout times of drugs defined under 7.4 cannot be adhered to; 14. Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the inhalatio devices; 15. Intolerance to salbutamol and excipients; 16. Beginning of immunotherapy during the patient's participation in the study or having begun an immunotherapy less than 3 months prior to visit B0 or alternation i regimen of an immunotherapy during the study period; c. Common criteria: 17. Pregnancy; 18. Intention to become pregnant during the course of the study; 19. Breast feeding; 20. Lack of safe contraception: Safe contraception is defined as follows: female patients of childbearing potential not using and not willing to continue using a medically reliable method of contraception for the entire study duration such as oral, injectable or implantable contraceptives or intrauterine contraceptive devices unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases; 21. Participation in another study within the 30 days preceding and during the present study; 22. Previous enrollment into the current study; 23. Enrollment of the investigator, his/her family members, employeees and other dependent persons; 24. Known or suspected non-compliance, alcohol or drug abuse; 25. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders; 26. Reversal of sleep pattern (e.g. night shift workers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of particle size of aerosolized AMP on the bronchial responsiveness in asthma. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of ciclesonide vs. fluticasone on large and small particile PC20 AMP. | — |
Contacts
Public ContactKatinka Mulder
University Medical Center Groningen (UMCG), Department of Internal Medicine, De Brug 4.089, P.O. Box 30.001
Outcome results
None listed