IgE mediated House dust mite induced mild to moderate asthma and mild to severe allergic rhinitis.
Conditions
Interventions
Product Name: ALK HDM tablet
Product Code: ALK HDM tablet
Pharmaceutical Form: Oral lyophilisate
Pharmaceutical form of the placebo: Oral lyophilisate
Route of administration of the placebo: Oromucosa
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females aged 14 years and above A clinical history of house dust mite induced mild to moderate persistent asthma of at least one year prior to trial entry. Use of an appropriate amount of inhaled corticosteroid (in accordance with the Gina Guidelines) for the control of the mild to moderate persistent asthma symptoms for a period of 6 month within the past year. At randomisation the asthma is considered stable and the intake of budesonide is 3mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. Positive specific IgE (>IgE Class 2) against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. A documented history of reversible airway obstruction. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: FEV1 < 70% of predicted value with appropriate medication. A clinical history of perennial allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites) A clinical history of chronic sinusitis A clinical history of severe asthma within the last two years. Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media not an exclusion criterion). Treatment by immunotherapy with HDM allergen within the previous 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of specific immunotherapy with three dosages of the ALK HDM tablet given once daily compared to placebo in subjects suffering from house dust mite allergy. The evaluation is based on reduction in inhaled corticosteroid (ICS) ;Secondary Objective: To evaluate the efficacy and safety of specific immunotherapy with three dosages of the ALK HDM tablet given once daily compared to placebo in subjects suffering from house dust mite allergy The efficacy evaluations are based on: Asthma control (ACQ) and use of asthma rescue medication, rhinoconjunctivitis symptoms and use of rhinoconjunctivitis symptoms and use of rhinoconjunctivitis rescue medication, number of asthma exacerbation, quality of life, lung function, and new sensitivities. The safety evaluations are based on Adverse Events(AEs), vital signs, haematology and clinical chemical analysis. ;Primary end point(s): The primary efficacy endpoint is deficned as reduction in ICS dosage from baseline to first year of treatment. | — |
Countries
Denmark, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed