CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

Cytos Biotechnology

Status and phase: Completed; Phase 2

Conditions: Allergic Bronchial Asthma

Treatments: Drug: CYT003-QbG10; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00890734

CYT003-QbG10 11

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: CYT003-QbG10

2

Placebo Comparator group

Treatment:

Drug: Placebo