CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Cytos Biotechnology AG

ClinicalTrials.gov Identifier:

NCT00890734

First received: April 28, 2009

Last updated: February 10, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 28, 2009
Last Updated Date	February 10, 2012
Start Date ^ICMJE	April 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 29, 2009)	Markers for inflammation and asthma [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00890734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Official Title ^ICMJE	A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Allergic Bronchial Asthma
Intervention ^ICMJE	Drug: CYT003-QbG10 subcutaneous injection Drug: Placebo subcutaneous injection
Study Arm (s)	Experimental: 1 Intervention: Drug: CYT003-QbG10 Placebo Comparator: 2 Intervention: Drug: Placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	63
Completion Date	November 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00890734
Other Study ID Numbers ^ICMJE	CYT003-QbG10 11
Has Data Monitoring Committee	No
Responsible Party	Cytos Biotechnology AG
Study Sponsor ^ICMJE	Cytos Biotechnology AG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cytos Biotechnology AG
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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