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

NCT01438463 | Completed Phase 2 DMC

• 1 other identifier: PM/0037
• Study Type: interventional
• Target: 290
• Locations: 5 countries
• Sites: 35

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

Keywords

non-seasonal allergy; house dust mite; immunotherapy; dose response

Outcome Measures

Primary Outcomes (1)

• Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test

  12 months

Secondary Outcomes (5)

• Sensitivity to HDM allergen assessed by a Nasal Provocation Test

  6 months

• Average Adjusted daily Symptom Score (AAdSS)

  last 2 months of treatment

• Peak Nasal Inspiratory Flow (PNIF)

  at each visit during 1 year treatment

• Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite

  6 and 12 months treatment

• Local and systemic reactions after injection as a measure of Safety and Tolerability

  24 hours after each injection during 1 year treatment

Study Arms (5)

placebo

PLACEBO COMPARATOR

Biological: Placebo

PURETHAL Mites, 6,667 AU/ml

EXPERIMENTAL

Biological: PURETHAL Mites 6,667 AU/ml

PURETHAL Mites, 20,000 AU/ml

EXPERIMENTAL

Biological: PURETHAL Mites 20,000 AU/ml

PURETHAL Mites, 50,000 AU/ml

EXPERIMENTAL

Biological: PURETHAL Mites 50,000 AU/ml

PURETHAL Mites, 100,000 AU/ml

EXPERIMENTAL

Biological: PURETHAL Mites 100,000 AU/ml

Interventions

Placebo 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.

placebo

PURETHAL Mites 6,667 AU/ml 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, 6,667 AU/ml

PURETHAL Mites 20,000 AU/ml 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

PURETHAL Mites 50,000 AU/ml 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

PURETHAL Mites 100,000 AU/ml 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (35)

Univ.-Klinik für Dermatologie und Venerologie

Innsbruck, A-6020, Austria

Location

Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde

Innsbruck, A-6020, Austria

Location

UZ Gent

Ghent, B-9000, Belgium

Location

UZ Leuven campus Sint Rafaël

Leuven, B-3000, Belgium

Location

CHU de Liège

Liège, B-4000, Belgium

Location

HNO-Praxis Dr. Hippke

Berlin, D-13057, Germany

Location

Universitätsklinikum Bonn

Bonn, D-53127, Germany

Location

HNO-Praxis

Chemnitz, D-09130, Germany

Location

Gemeinschaftspraxis Pneumologie und Allergologie Dr. Hans-Christian Blum

Dortmund, D-44263, Germany

Location

HNO-Praxis Dr. U. Thieme

Duisburg, D-47051, Germany

Location

Medizinisches Versorgungszentrum

Düren, D-52351, Germany

Location

Universitätsklinikum Erlangen

Erlangen, D-91052, Germany

Location

HNO Gemeinschaftspraxis

Göttingen, D-37073, Germany

Location

Pneumologische Praxis Hannover Nordstadt

Hanover, D-30167, Germany

Location

HNO Gemeinschaftspraxis

Heidelberg, D-69126, Germany

Location

HNO-Praxis

Jülich, D-52428, Germany

Location

POIS Leipzig GbR

Leipzig, D-04357, Germany

Location

CRS Clinical Research Services Mannheim GmbH

Mannheim, D-68167, Germany

Location

CRS Clinical Research Services Möchengladbach GmbH

Mönchengladbach, D-41061, Germany

Location

Gemeinschaftspraxis HNO/Allergologie

München, D-80331, Germany

Location

Klinikum der Universität München

München, D-80337, Germany

Location

Pneumologie Odeonsplatz

München, D-80539, Germany

Location

HNO-Praxis

Pirna, D-01796, Germany

Location

Praxisgemeinschaft Reiber & Partner

Schorndorf, D-73614, Germany

Location

Universitätsklinikum Stuttgart

Stuttgart, D-70374, Germany

Location

Hautarztpraxis

Stuttgart, D-70499, Germany

Location

Zentrum für Rhinologie und Allergologie

Wiesbaden, D-65183, Germany

Location

EB FlevoResearch

Almere Stad, NL-1311 RL, Netherlands

Location

Allergologie Praktijk Arnhem (APA)

Arnhem, NL-6824 BJ, Netherlands

Location

Albert Schweitzer (Amstelwijck)

Dordrecht, NL-3317 NM, Netherlands

Location

QPS Onderzoekskliniek Universitair Medisch Centrum Groningen

Groningen, NL-9713 GZ, Netherlands

Location

St. Elisabethziekenhuis

Tilburg, NL-5022 GC, Netherlands

Location

Hospital Clinico Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Germans Trios i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitari Politecnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Claus Bachert, PhD, MD

  University Gent, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

AU (2); BE (3); NL (5); DE (22); ES (3)