Allergic Rhinitis Clinical Trial
Official title:
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Identify the Optimal Dose of PURETHAL® Mites SCIT in Patients With House Dust Mites-induced Persistent Allergic Rhinitis/Rhinoconjunctivitis
The objective of the present study is to characterize the dose-response relationship of
PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms
of clinical efficacy and safety.
For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due
to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of
treatment and at the end of the study patients will be subjected to a nasal provocation
test.
Status | Completed |
Enrollment | 290 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Patients (male or female) must be = 18 and = 60 years at screening - Patients with allergic rhinitis or rhinoconjunctivitis for at least 1 year; allergic symptoms related to HDM, with or without concomitant clinically stable controlled mild to moderate asthma (according to GINA classification) - Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80%. - Positive SPT to HDM D. pter and/or D. far - Serum specific IgE-test (ssIgE) level for HDM D. pter or D. far at screening - Positive nasal provocation test for HDM extract at screening Exclusion Criteria: - Current clinically relevant symptoms of seasonal rhinitis/rhinoconjunctivitis caused by other allergen(s) than HDM (with a demonstrated positive SPT for this allergen) at the time of inclusion - Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals - Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years - Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the past 5 years - Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period - Any vaccination one week before start of therapy and during the up-dosing phase - Any anti-IgE therapy within the last 6 months prior to inclusion and during study - Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs - Active malignancies or any malignant disease in the past 5 years - A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders - Moderate to severe nasal obstructive diseases such as polyps, septal deviations etc. - Clinically significant chronic sinusitis or ocular infection - Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) - Use of systemic corticosteroids within 4 weeks of screening - Treatment with systemic or local b-blockers - Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study - Pregnancy, lactation or inadequate contraceptive measures (contraceptive measures considered as adequate include appropriate use of oral contraception, i.m. contraception or a contraceptive device) - Alcohol, drug, or medication abuse within the past year and during study - Any abnormal laboratory parameter at screening that in the opinion of the investigator is considered clinically relevant - Lack of co-operation or compliance - Severe psychiatric, psychological, or neurological disorders - Patients who are employees of the department, 1st grade relatives, or partners of the investigator - Expected changes in HDM exposure during the study (avoidance measures, move, etc.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Univ.-Klinik für Dermatologie und Venerologie | Innsbruck | |
Austria | Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde | Innsbruck | |
Belgium | UZ Gent | Gent | |
Belgium | UZ Leuven campus Sint Rafaël | Leuven | |
Belgium | CHU de Liège | Liège | |
Germany | HNO-Praxis Dr. Hippke | Berlin | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | HNO-Praxis | Chemnitz | |
Germany | Gemeinschaftspraxis Pneumologie und Allergologie Dr. Hans-Christian Blum | Dortmund | |
Germany | HNO-Praxis Dr. U. Thieme | Duisburg | |
Germany | Medizinisches Versorgungszentrum | Düren | |
Germany | Universitätsklinikum Erlangen | Erlangen | |
Germany | HNO Gemeinschaftspraxis | Göttingen | |
Germany | Pneumologische Praxis Hannover Nordstadt | Hannover | |
Germany | HNO Gemeinschaftspraxis | Heidelberg | |
Germany | HNO-Praxis | Jülich | |
Germany | POIS Leipzig GbR | Leipzig | |
Germany | CRS Clinical Research Services Mannheim GmbH | Mannheim | |
Germany | CRS Clinical Research Services Möchengladbach GmbH | Mönchengladbach | |
Germany | Gemeinschaftspraxis HNO/Allergologie | München | |
Germany | Klinikum der Universität München | München | |
Germany | Pneumologie Odeonsplatz | München | |
Germany | HNO-Praxis | Pirna | |
Germany | Praxisgemeinschaft Reiber & Partner | Schorndorf | |
Germany | Hautarztpraxis | Stuttgart | |
Germany | Universitätsklinikum Stuttgart | Stuttgart | |
Germany | Zentrum für Rhinologie und Allergologie | Wiesbaden | |
Netherlands | EB FlevoResearch | Almere | |
Netherlands | Allergologie Praktijk Arnhem (APA) | Arnhem | |
Netherlands | Albert Schweitzer (Amstelwijck) | Dordrecht | |
Netherlands | QPS Onderzoekskliniek Universitair Medisch Centrum Groningen | Groningen | |
Netherlands | St. Elisabethziekenhuis | Tilburg | |
Spain | Hospital Clinico Barcelona | Barcelona | |
Spain | Hospital Universitario Germans Trios i Pujol | Barcelona | |
Spain | Hospital Universitari Politecnic La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
HAL Allergy |
Austria, Belgium, Germany, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test | 12 months | No | |
Secondary | Sensitivity to HDM allergen assessed by a Nasal Provocation Test | 6 months | No | |
Secondary | Average Adjusted daily Symptom Score (AAdSS) | last 2 months of treatment | No | |
Secondary | Peak Nasal Inspiratory Flow (PNIF) | at each visit during 1 year treatment | No | |
Secondary | Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite | 6 and 12 months treatment | No | |
Secondary | Local and systemic reactions after injection as a measure of Safety and Tolerability | 24 hours after each injection during 1 year treatment | Yes |
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