CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

Allergic Bronchial Asthma Clinical Trial

Official title:

A Double-blind, Placebo-controlled Study to Assess Pharmacodynamic and Clinical Efficacy of CYT003-QbG10 in Patients With Persistent Allergic Asthma Bronchial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890734
• Other study ID #: CYT003-QbG10 11
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: February 10, 2012
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Bronchial Asthma
• Asthma

Intervention

Drug:
• CYT003-QbG10
subcutaneous injection
• Placebo
subcutaneous injection

Locations

Country	Name	City	State
Germany	Cytos Investigator Sites	Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers for inflammation and asthma		1-3 months	No