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CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

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ClinicalTrials.gov Identifier: NCT00890734
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Allergic Bronchial Asthma Drug: CYT003-QbG10 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2009
Primary Completion Date : April 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: CYT003-QbG10
subcutaneous injection
Placebo Comparator: 2 Drug: Placebo
subcutaneous injection


Outcome Measures

Primary Outcome Measures :
  1. Markers for inflammation and asthma [ Time Frame: 1-3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890734


Locations
Germany
Cytos Investigator Sites
Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach, Germany
Sponsors and Collaborators
Cytos Biotechnology AG
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00890734     History of Changes
Other Study ID Numbers: CYT003-QbG10 11
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases