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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660452
• Other study ID #: VO55.06 CHIN
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: October 10, 2011
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: October 2011
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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 ß2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Staloral
Sublingual immunotherapy with Staloral dust mites solution

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital -	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo		September 2009	No
Secondary	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	No