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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574704
First received: December 14, 2007
Last updated: June 4, 2013
Last verified: February 2013
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT00574704

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

No publications provided

Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00574704     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 03
Study First Received: December 14, 2007
Results First Received: February 14, 2013
Last Updated: June 4, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 25, 2014