A double-blind placebo controlled dose-response study for evaluation of safety and efficacy of immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) adsorbed onto aluminium hydroxide in patients with IgE-mediated allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma - ADRET-Trial: Recombinant Phleum - Dose-response Study

• Conditions: ICD classification code: J45.0 and J30.1; MedDRA version: 9.1Level: LLTClassification code 10039085Term: Rhinitis allergic; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2007-002808-18-DE
• Lead Sponsor: ALLERGOPHARMA JOACHIM GANZER KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Male and female outpatients, 18-50 years
- Patients with IgE-mediated, moderate to severe seasonal allergic rhinitis with controlled asthma (FEV1 at least 80% predicted normal according to ECCS (GINA 2006)), attributable to grass pollen allergens
- Main symptoms of allergic rhinitis/rhinoconjunctivitis against grass pollen allergens and
- Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test result using natural grass pollen extract
and
- Positive prick test reaction to natural grass pollen allergen demonstrated by allergen weal at least as large as histamine control reaction (histaminedihydrochloride 1,7mg/ml histamine, 0,1%) and > 5 mm diameter and a negative control test (saline solution). A positive histamine control reaction is demonstrated by weal diameter >=3mm, a negative control test is demonstrated by weal diameter <3mm) and
- Positive EAST (Allergopharma Joachim Ganzer KG) to grass pollen >= 2 measured by Central Lab
- For female patients: effective contraception and negative pregnancy test result

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous course of hyposensitation against grass pollen or other allergens that are not known
- Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen
- Symptoms during the months Nov-April and skin test positivity (weal diameter = histamine 0,1% or >= 5 mm) to birch alder, hazel, Dermatophagoides pteronyssinus, Dermatophagoides farinae, dog, cat, Aspergillus, Penicillium. Alternaria and Cladosporium if clinical relevance of this sensitisation cannot be excluded by provocation test.
- Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified
- FEV1 < 80 % of predicted normal (ECCS) or partly controlled/uncontrolled bronchial asthma according to GINA 2006
- Patients that are not adequately treated with a short acting ß2-Mimetic and 500 µg BDP or 400µg budesonide (equiv.).
- Vasomotor, drug-induced or other kinds of non allergic rhinoconjunctivitis
- Febrile infections or inflammation of the respiratory tract at time of inclusion
- Irreversible secondary alterations of the reactive organ
- Severe acute or chronic diseases, severe inflammatory diseases
- Other severe generalised diseases (liver, kidneys, metabolic diseases, heart, vascular diseases)
-contra-indication for adrenaline (for example acut or chronic symptomatic coronary heart disease, severe hypertension)
- Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
- Multiple sclerosis, active tuberculosis
-complete or ongoing treatment with transquillizer or psychoactive drugs
- Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- Treatment that could interfere with safety and/or efficacy of the study drug (e.g. treatment with beta-Blockers (locally and systemic), systemic glucocorticoids, leucotrien-antagonists, anti-IgE etc.) during the course of the study
- Pregnancy and lactation period
- Female patients seeking to become pregnant
- Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- Patients being in any relationship of dependence with the Sponsor and/or with the Investigator.
- Low compliance or inability to understand instructions/study documents

Study & Design

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