Clinical trial NCT00660452: A Phase III Study to Assess Efficacy and Safety of STALORAL® 300 IR Sublingual Immunotherapy (SLIT) in Asthmatic Patients Allergic to House-dust Mites
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Allergy
SLIT
Asthma
House Dust Mites
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 484
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo
timeFrame: September 2009
Secondary outcomes:
measure: 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
timeFrame: September 2009
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital -
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jia YIN, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
citation: Devillier P, Fadel R, de Beaumont O. House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial. Allergy. 2016 Feb;71(2):249-57. doi: 10.1111/all.12791. Epub 2015 Nov 6.
citation: Wang L, Yin J, Fadel R, Montagut A, de Beaumont O, Devillier P. House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma. Allergy. 2014 Sep;69(9):1181-8. doi: 10.1111/all.12188. Epub 2014 Jul 24.