Efficacy of SLITone in House Dust Mite Allergic Patients

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S
• Treatments: Albuterol; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Desloratadine; Formoterol Fumarate; Prednisone

Criteria

Inclusion Criteria:

• A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution.

• Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent).

• Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix.

• If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test.

• Willingness to comply with this protocol.

Exclusion Criteria:

• FEV1 < 70% of predicted value with appropriate medication.

• Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent.

• A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites.

• Chronic sinusitis.

• Aspirin or sulfite intolerance.

• Chronic obstructive pulmonary disease.

• Current severe atopic dermatitis.

• Severe asthma.

• Use of an investigational drug within 30 days prior to screening.

• Previous immunotherapy with house dust mite allergens for at least 2 years within the previous 10 years.

• At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (se-rous otitis media is not an exclusion criterion).

• Physical examination with clinically relevant findings.

• Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic disease).

• Immunosuppressive treatment.

• A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude.

• Unlikely to be able to complete the trial.

• Unwillingness to comply with trial protocol regimen for asthma and/or rhinoconjunctivitis medication.