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

House Dust Mite Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574704
• Other study ID #: CYT005-AllQbG10 03
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2007
• Last updated: June 4, 2013
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2013
• Source: Cytos Biotechnology AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• House Dust Mite Allergy
• Perennial Allergic Rhinoconjunctivitis

Intervention

Drug:
• CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 6 visits
• House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 6 visits
• CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits
• CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
subcutaneous injections at 6 visits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytos Biotechnology AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	baseline versus 2 months after baseline	No
Secondary	Safety and Tolerability of the Study Treatment by Collection of Adverse Events		about 30 min. at each visit	No