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

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Drug: Staloral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660452

VO55.06 CHIN

Details and patient eligibility

About

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.

Enrollment: 484 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female outpatients aged 16 to 50 years (inclusive).
2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
3. 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
4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day.

Exclusion criteria

1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
3. FEV1 < 70% of predicted value at Visit 1.
4. 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 .
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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484 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

360 active patients with house dust mites related asthma with or without allergic rhinitis

Treatment:

Drug: Staloral

2

Placebo Comparator group

Description:

180 patients in the placebo group with house -dust mites related asthma with or without allergic rhinitis.

Treatment:

Drug: Staloral