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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT01438463
First received: September 20, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Biological: Placebo
Biological: PURETHAL Mites 6,667 AU/ml
Biological: PURETHAL Mites 20,000 AU/ml
Biological: PURETHAL Mites 50,000 AU/ml
Biological: PURETHAL Mites 100,000 AU/ml
Phase 2

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

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity to HDM allergen assessed by a Nasal Provocation Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average Adjusted daily Symptom Score (AAdSS) [ Time Frame: last 2 months of treatment ] [ Designated as safety issue: No ]
  • Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: at each visit during 1 year treatment ] [ Designated as safety issue: No ]
  • Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite [ Time Frame: 6 and 12 months treatment ] [ Designated as safety issue: No ]
  • Local and systemic reactions after injection as a measure of Safety and Tolerability [ Time Frame: 24 hours after each injection during 1 year treatment ] [ Designated as safety issue: Yes ]

Enrollment: 290
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo 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.
Experimental: PURETHAL Mites, 6,667 AU/ml 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.
Experimental: PURETHAL Mites, 20,000 AU/ml 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.
Experimental: PURETHAL Mites, 50,000 AU/ml 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.
Experimental: PURETHAL Mites, 100,000 AU/ml 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438463

Locations
Austria
Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde
Innsbruck, Austria, A-6020
Univ.-Klinik für Dermatologie und Venerologie
Innsbruck, Austria, A-6020
Belgium
UZ Gent
Gent, Belgium, B-9000
UZ Leuven campus Sint Rafaël
Leuven, Belgium, B-3000
CHU de Liège
Liège, Belgium, B-4000
Germany
HNO-Praxis Dr. Hippke
Berlin, Germany, D-13057
Universitätsklinikum Bonn
Bonn, Germany, D-53127
HNO-Praxis
Chemnitz, Germany, D-09130
Gemeinschaftspraxis Pneumologie und Allergologie Dr. Hans-Christian Blum
Dortmund, Germany, D-44263
HNO-Praxis Dr. U. Thieme
Duisburg, Germany, D-47051
Medizinisches Versorgungszentrum
Düren, Germany, D-52351
Universitätsklinikum Erlangen
Erlangen, Germany, D-91052
HNO Gemeinschaftspraxis
Göttingen, Germany, D-37073
Pneumologische Praxis Hannover Nordstadt
Hannover, Germany, D-30167
HNO Gemeinschaftspraxis
Heidelberg, Germany, D-69126
HNO-Praxis
Jülich, Germany, D-52428
POIS Leipzig GbR
Leipzig, Germany, D-04357
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, D-68167
CRS Clinical Research Services Möchengladbach GmbH
Mönchengladbach, Germany, D-41061
Klinikum der Universität München
München, Germany, D-80337
Pneumologie Odeonsplatz
München, Germany, D-80539
Gemeinschaftspraxis HNO/Allergologie
München, Germany, D-80331
HNO-Praxis
Pirna, Germany, D-01796
Praxisgemeinschaft Reiber & Partner
Schorndorf, Germany, D-73614
Universitätsklinikum Stuttgart
Stuttgart, Germany, D-70374
Hautarztpraxis
Stuttgart, Germany, D-70499
Zentrum für Rhinologie und Allergologie
Wiesbaden, Germany, D-65183
Netherlands
EB FlevoResearch
Almere, Netherlands, NL-1311 RL
Allergologie Praktijk Arnhem (APA)
Arnhem, Netherlands, NL-6824 BJ
Albert Schweitzer (Amstelwijck)
Dordrecht, Netherlands, NL-3317 NM
QPS Onderzoekskliniek Universitair Medisch Centrum Groningen
Groningen, Netherlands, NL-9713 GZ
St. Elisabethziekenhuis
Tilburg, Netherlands, NL-5022 GC
Spain
Hospital Universitario Germans Trios i Pujol
Barcelona, Spain, 08916
Hospital Clinico Barcelona
Barcelona, Spain, 08036
Hospital Universitari Politecnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
HAL Allergy
Investigators
Study Chair: Claus Bachert, PhD, MD University Gent, Belgium
  More Information

No publications provided

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT01438463     History of Changes
Other Study ID Numbers: PM/0037
Study First Received: September 20, 2011
Last Updated: May 28, 2013
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by HAL Allergy:
non-seasonal allergy
house dust mite
immunotherapy
dose response

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Rhinitis
Conjunctivitis
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014