Back to resultsCYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Primary Purpose
Allergic Bronchial Asthma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CYT003-QbG10
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Bronchial Asthma
Eligibility Criteria
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
Sites / Locations
- Cytos Investigator Sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Markers for inflammation and asthma
Secondary Outcome Measures
Full Information
NCT ID
NCT00890734
First Posted
April 28, 2009
Last Updated
February 10, 2012
Sponsor
Cytos Biotechnology AG
1. Study Identification
Unique Protocol Identification Number
NCT00890734
Brief Title
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Official Title
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytos Biotechnology AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchial Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CYT003-QbG10
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
Markers for inflammation and asthma
Time Frame
1-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cytos Investigator Sites
City
Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23384679
Citation
Beeh KM, Kanniess F, Wagner F, Schilder C, Naudts I, Hammann-Haenni A, Willers J, Stocker H, Mueller P, Bachmann MF, Renner WA. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-74. doi: 10.1016/j.jaci.2012.12.1561. Epub 2013 Feb 4.
Results Reference
derived
Learn more about this trial
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
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