Status:
COMPLETED
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
Lead Sponsor:
HAL Allergy
Conditions:
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01438463
Start Date
September 1 2011
End Date
May 1 2013
Last Update
May 29 2013
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Univ.-Klinik für Dermatologie und Venerologie
Innsbruck, Austria, A-6020
2
Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde
Innsbruck, Austria, A-6020
3
UZ Gent
Ghent, Belgium, B-9000
4
UZ Leuven campus Sint Rafaël
Leuven, Belgium, B-3000