NCT01438463CompletedPhase 2
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
HAL Allergy67 sites in 5 countries290 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 290
- Locations
- 67
- Primary Endpoint
- Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.)
Outcomes
Primary Outcomes
Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test
Time Frame: 12 months
Secondary Outcomes
- 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)
Investigators
Study Sites (67)
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