Status:
COMPLETED
Effect of High Dose Ciclesonide on Asthma Control
Lead Sponsor:
AstraZeneca
Conditions:
Bronchial Asthma
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).
Eligibility Criteria
Inclusion
- Written informed consent was provided
- History of persistent bronchial asthma for at least 6 months
- Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
- Good inhalation technique
- Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2
Exclusion
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
- 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)
- Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT01455194
Start Date
November 1 2011
End Date
August 1 2014
Last Update
February 10 2017
Active Locations (30)
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1
Buenos Aires, Argentina
2
Capital Federal, Buenos Aires, Argentina
3
Rosario, Argentina
4
Rosario-Santa Fe, Argentina