NCT00890734
Completed
Phase 2
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cytos Biotechnology AG
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Markers for inflammation and asthma
Overview
Brief Summary
The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
- •Further criteria as defined in the study protocol
Exclusion Criteria
- •Use of oral corticosteroids within past 3 months
- •Hospitalization for asthma exacerbation within past 6 months
- •Uncontrolled asthma
- •Contraindication to any study test or procedure
- •Further criteria as defined in the study protocol
Arms & Interventions
1
Experimental
Intervention: CYT003-QbG10 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Markers for inflammation and asthma
Time Frame: 1-3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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