Completed

NCT Number: NCT00574704

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

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

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Key information

Conditions

Perennial Allergic Rhinoconjunctivitis Dust Mite Allergy House Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)

Drug

subcutaneous injections at 6 visits

House dust mite allergen extract in combination with CYT003-QbG10-placebo

Drug

subcutaneous injections at 6 visits

CYT003-AllQbG10 in combination with house dust mite allergen extract placebo

Drug

subcutaneous injections at 6 visits

CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

Drug

subcutaneous injections at 6 visits

Primary outcomes

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 outcomes

Safety and Tolerability of the Study Treatment by Collection of Adverse Events

Time frame: about 30 min. at each visit

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Dec 17, 2007
Registry last updated: Jul 11, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed