Persistent allergic rhinitis or rhinoconjunctivitis with or without concomitant mild to moderate asthma induced by house dust mite (HDM) allergy (or sensitization). MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Sponsors
HAL Allergy B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Patients (male or female) must be = 18 and = 60 years at screening 3. 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) (Koshak, 2007) 4. 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%. 5. Positive SPT to HDM D. pter and/or D. far (mean wheal diameter = 3mm compared to negative control and negative control should be negative, assessed within 1 year before randomization) 6. Serum specific IgE-test (ssIgE) level for HDM Der p or Der f at sreening (> 0.7 U/ml) 7. Positive TNPT for HDM D. pter extract at screening (Lebel score =6 at or below 10,000 AU/ml) [Lebel, 1988] Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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 (to avoid interference with TNPT at inclusion) 2. Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals 3. Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years 4. Completed unsuccessful allergen-specific immunotherapy (subcuteanous or sublingual immunotherapy) within the past 5 years 5. Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period 6. Any vaccination one week before start of therapy and during the up-dosing phase 7. Any anti-IgE therapy within the last 6 months prior to inclusion and during study 8. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs 9. Active malignancies or any malignant disease in the past 5 years 10. 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 hematological disorders 11. Moderate to severe nasal obstructive diseases such as polyps, septal deviations etc. 12. Clinically significant chronic sinusitis or ocular infection 13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma) 14. Use of systemic corticosteroids within 4 weeks of screening 15. Treatment with systemic or local b-blockers 16. 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 17. Pregnancy, lactation or inadequate contraceptive measures (contraceptive measures considered as adequate include appropriate use of oral contraception, i.m. contraception or a contraceptive device) 18. Alcohol, drug, or medication abuse within the past year and during study 19. Any abnormal laboratory parameter at screening that in the opinion of the investigator is considered clinically relevant 20. Lack of co-operation or compliance 21. Severe psychiatric, psychological, or neurological disorders 22. Patients who are employees of the institution, 1st grade relatives, or partners of the investigator 23. Expected changes in HDM exposure during the study (avoidance measures, move, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to characterize the dose-response relationship of PM with a titrated nasal provocation test using four different PM doses in order to identify the optimal dose in terms of highest clinical efficacy and safety.;Secondary Objective: ;Primary end point(s): The primary endpoint is the absolute difference in mean symptom score in the TNPT between one year of treatment and baseline, among the different PM dose groups versus placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Absolute difference in mean symptom score in the TNPT between 22-30 weeks of treatment and baseline, among the different PM dose groups versus placebo. • Average Adjusted Symptom Score (AdSS) measured during the last 8 weeks of treatment, among the different PM dose groups versus placebo (EMA Guideline, 2008; Grouin, 2011) • Peak Nasal Inspiratory Flow (PNIF) measurements during the entire study period, among the different PM dose groups versus placebo • Serum immunoglobulin levels measured at baseline, between 22 and 30 weeks and after approximately 1 year of treatment, among the different PM dose groups versus placebo • Safety and tolerability among different PM dose groups versus placebo will be assessed during the entire study period by determination of PM related adverse events and by local and systemic reactions (reporting according to the Medical Dictionary for Regulatory Affairs (MedDRA) (Cox, 2010) | — |
Countries
Austria, Belgium, Germany, Netherlands, Spain
Contacts
Public ContactClinical Trial Management
HAL Allergy B.V.
Outcome results
None listed