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

Phase 2

Completed

• Conditions: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy
• Interventions: 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

• Registration Number: NCT00574704
• Lead Sponsor: Cytos Biotechnology AG

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2013-02
• Results First Submitted: 2013-02-14
• Results First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Results First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)	-
2	House dust mite allergen extract in combination with CYT003-QbG10-placebo	-
3	CYT003-AllQbG10 in combination with house dust mite allergen extract placebo	-
4	CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo	-

Primary Outcome Measures

Name	Time	Method
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)	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

Name	Time	Method
Safety and Tolerability of the Study Treatment by Collection of Adverse Events	about 30 min. at each visit