PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis

NCT ID: NCT01438463

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.

PURETHAL Mites, 6,667 AU/ml

Group Type: EXPERIMENTAL

PURETHAL Mites 6,667 AU/ml

Intervention Type: BIOLOGICAL

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

PURETHAL Mites, 20,000 AU/ml

Group Type: EXPERIMENTAL

PURETHAL Mites 20,000 AU/ml

Intervention Type: BIOLOGICAL

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

PURETHAL Mites, 50,000 AU/ml

Group Type: EXPERIMENTAL

PURETHAL Mites 50,000 AU/ml

Intervention Type: BIOLOGICAL

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

PURETHAL Mites, 100,000 AU/ml

Group Type: EXPERIMENTAL

PURETHAL Mites 100,000 AU/ml

Intervention Type: BIOLOGICAL

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Interventions

Placebo

Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

PURETHAL Mites 6,667 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

PURETHAL Mites 20,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

PURETHAL Mites 50,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

PURETHAL Mites 100,000 AU/ml

Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAL Allergy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Bachert, PhD, MD

Role: STUDY_CHAIR

University Gent, Belgium

Locations

Univ.-Klinik für Dermatologie und Venerologie

Innsbruck, , Austria

Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde

Innsbruck, , Austria

UZ Gent

Ghent, , Belgium

UZ Leuven campus Sint Rafaël

Leuven, , Belgium

CHU de Liège

Liège, , Belgium

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

Hanover, , 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

Universitätsklinikum Stuttgart

Stuttgart, , Germany

Hautarztpraxis

Stuttgart, , Germany

Zentrum für Rhinologie und Allergologie

Wiesbaden, , Germany

EB FlevoResearch

Almere Stad, , Netherlands

Allergologie Praktijk Arnhem (APA)

Arnhem, , Netherlands

Albert Schweitzer (Amstelwijck)

Dordrecht, , Netherlands

QPS Onderzoekskliniek Universitair Medisch Centrum Groningen

Groningen, , Netherlands

St. Elisabethziekenhuis

Tilburg, , Netherlands

Hospital Clinico Barcelona

Barcelona, , Spain

Hospital Universitario Germans Trios i Pujol

Barcelona, , Spain

Hospital Universitari Politecnic La Fe

Valencia, , Spain

Countries

Austria; Belgium; Germany; Netherlands; Spain

Other Identifiers

PM/0037

Identifier Type: -

Identifier Source: org_study_id