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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00660452

Enrollment

484

Registered

2008-04-17

Start date

2007-10-31

Completion date

2009-07-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

Allergy, SLIT, Asthma, House Dust Mites

Brief summary

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.

Interventions

DRUGStaloral

Sublingual immunotherapy with Staloral dust mites solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026