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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01438463
Other study ID # PM/0037
Secondary ID
Status Completed
Phase Phase 2
First received September 20, 2011
Last updated May 28, 2013
Start date September 2011
Est. completion date May 2013

Study information

Verified date May 2013
Source HAL Allergy
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Biological:
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.
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.
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.
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.
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
HAL Allergy

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Netherlands,  Spain, 

Outcome

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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