Efficacy and safety of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® (glutaraldehyde-polymerized allergen extract of mixtures of grass and rye allergens – Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca elatior, Secale cereale) in patients with allergic rhinoconjunctivitis sensitized to grass and with or without rye pollen sensitization. A prospective, double-blind, randomized, placebo-controlled, multi-centre trial. - Specific Immunotherapy with CLUSTOID®: Efficacy and safety

• Conditions: This clinical trial will evaluate the benefit of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® over placebo in patients with allergic rhinoconjunctivits.

• Registration Number: EUCTR2008-000513-29-DE
• Lead Sponsor: ROXALL Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal mild or moderate allergic asthma (GINA I and GINA II).
•Positive clinical history of grass pollen.
•Clinical sensitization to grass with or without additional sensitization to rye pollen.
•Compliance and ability of the patient to complete a Diary Card
•Signed and dated patient´s informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous immunotherapy with grass or rye pollen extracts within the last 3 years,
•Predominant perennial allergic rhinitis,
•Predominant perennial allergic asthma,
•Simultaneous participation in other clinical trials,
•Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
•Active tuberculosis,
•Auto-immune disorders,
•Severe chronic-inflammatory diseases,
•Malignancy,
•Alcohol abuse,
•Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
•Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis),
•Patients treated with ?-blockers and/or other contra-indicated drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified