To test if higher doses of ciclesonide bring a better control of asthma

• Conditions: moderate or severe asthma; MedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-000683-99-DE
• Lead Sponsor: Takeda Development Centre Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Written informed consent was provided,
2. Age between 18 and 70 years,
3. History of persistent bronchial asthma (GINA 2009) for at least 6 months
4. Current treatment with an ICS at a stable dose in the dose range of 200-1000µg FP/day or equivalent for a minimum of 12 weeks,
5. Under the current ICS pre-treatment an ACQ score as defined below:
ICS pre-treatment dose: low dose ICS (FP 200 – 250µg/day or equivalent); ACQ at start of baseline minimum 2
ICS pre-treatment dose: medium or high dose ICS (FP >250 – 1000µg/day or equivalent); ACQ at start of baseline between 0.75 and < 2
6. Good inhalation technique
7. Certified asthma training has been completed

Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

a) Diseases and health status:
1. Clinically relevant abnormal laboratory values and vital signs suggesting an unknown underlying disease and requiring further clinical evaluation (as assessed by the investigator),
2. Any malignant disease (other than basal or squamous cell carcinoma) within 5 years before trial start,
3. Other concomitant severe diseases (e.g. hepatitis C, AIDS),
4. Diseases which are contraindications for the use of ICS (e. g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment),
5. The subject suffers from Chronic Obstructive Pulmonary Disease (COPD) and/or other relevant lung diseases associated with impaired lung function,
6. Severe psychiatric or neurological disorders,
7. Current or previous smoking with more than a 10 pack-years.

b) Medications:
9. Use of other drugs not allowed,
10. Washout times of drugs defined cannot be adhered to,
11. Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the ciclesonide MDIs,
12. Intolerance to short-acting beta agonists and/or to the excipients of salbutalmol MDI,
13. Start of immunotherapy either during the subject’s participation in the trial or less than three months prior to enrolment, or changes in the regimen during the trial period.

c) Common criteria:
14. Participation in another clinical trial with an investigational drug or device within 30 days before inclusion in this trial and during the present trial,
15. Previous participation in this trial,
16. Enrolment of the investigator, his/her family members and employees at the site,
17. Known or suspected non-compliance, alcohol or drug abuse,
18. Inability to follow the procedures of the trial, e.g. due to language problems, psychological disorders or dementia,
19. Planned relocation during the trial period to an area outside the operating distance of the investigator,
20. Planned prolonged absence (e.g. holiday) in which the subject cannot be reached via phone.

For females of childbearing potential, i.e. not postmenopausal (less than 12 months after last menstruation) or not surgically sterile:
21. A positive pregnancy test before the first administration of investigational medicinal product,
22. No acceptable contraceptive method. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs with copper or progestogen), sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, there are no known interactions with ciclesonide,
23. Intention to become pregnant during the course of the trial,
24. Breast feeding,
25. the person concerned has not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified