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Completed

NCT Number: NCT00890734

CYT003-QbG10 for Treatment of 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.

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Key information

Conditions

Allergic Bronchial Asthma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cytos Investigator Sites

Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CYT003-QbG10

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Markers for inflammation and asthma

    Time frame: 1-3 months

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2009
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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