A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites

Study Overview
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Brief Summary
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A phase III study to assess the efficacy and safety of sublingual immunotherapy with STALORAL dust mites solution compared with placebo for reduction of asthma symptoms.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Chinese Asthmatic Patients Allergic to House-dust Mites

Conditions
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Allergy

Intervention / Treatment
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* Drug: Staloral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients aged 16 to 50 years (inclusive). House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day. Exclusion Criteria: Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1). Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide. FEV1 < 70% of predicted value at Visit 1. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L . Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>360 active patients with house dust mites related asthma with or without allergic rhinitis | Drug: Staloral<br>* Sublingual immunotherapy with Staloral dust mites solution<br>|
| Placebo Comparator: 2<br>180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis. | Drug: Staloral<br>* Sublingual immunotherapy with Staloral dust mites solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo |  | September 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily dose of steroids at the endpoint Number of asthma exacerbations Asthma Control Questionnaire(ACQ)score Asthma Quality of Life Questionnaire (AQLQ) score Lung Function Parameters ( FEV1; FEF 25-75 %; PEF) Allergic rhinitis g |  | September 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, SLIT, Asthma, House Dust Mites