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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

April 28, 2009
February 10, 2012
April 2009
April 2010   (final data collection date for primary outcome measure)
Markers for inflammation and asthma [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00890734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Bronchial Asthma
  • Drug: CYT003-QbG10
    subcutaneous injection
  • Drug: Placebo
    subcutaneous injection
  • Experimental: 1
    Intervention: Drug: CYT003-QbG10
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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.
 
Completed
63
November 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00890734
CYT003-QbG10 11
No
Cytos Biotechnology AG
Cytos Biotechnology AG
Not Provided
Not Provided
Cytos Biotechnology AG
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP