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A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574704
First Posted: December 17, 2007
Last Update Posted: July 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cytos Biotechnology AG
  Purpose
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting

Condition Intervention Phase
Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) [ Time Frame: baseline versus 2 months after baseline ]

    The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).

    The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.



Secondary Outcome Measures:
  • Safety and Tolerability of the Study Treatment by Collection of Adverse Events [ Time Frame: about 30 min. at each visit ]

Enrollment: 40
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 6 visits
Placebo Comparator: 2 Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 6 visits
Experimental: 3 Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
Placebo Comparator: 4 Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits

  Eligibility

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:

  • Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

  • Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
  • Use of any concomitant medication that could affect the patient's study treatment response or assessment results
  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): NCT00574704


Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Study Director: Philipp Mueller, MD Cytos Biotechnology
  More Information

Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00574704     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 03
First Submitted: December 14, 2007
First Posted: December 17, 2007
Results First Submitted: February 14, 2013
Results First Posted: July 11, 2013
Last Update Posted: July 11, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Conjunctivitis, Allergic
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate