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
  Purpose

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 Intervention Phase
Allergic Bronchial Asthma
Drug: CYT003-QbG10
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Markers for inflammation and asthma [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CYT003-QbG10
subcutaneous injection
Placebo Comparator: 2 Drug: Placebo
subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890734

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

No publications provided by Cytos Biotechnology AG

Additional 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
Study First Received: April 28, 2009
Last Updated: February 10, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on July 23, 2014