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

Primary Purpose

Allergy

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Staloral

About this trial

This is an interventional treatment trial for Allergy focused on measuring Allergy, SLIT, Asthma, House Dust Mites

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Peking Union Medical College Hospital -

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00660452

First Posted

April 15, 2008

Last Updated

October 10, 2011

Sponsor

Stallergenes Greer

1. Study Identification

Unique Protocol Identification Number

NCT00660452

Brief Title

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

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stallergenes Greer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

Keywords

Allergy, SLIT, Asthma, House Dust Mites

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

484 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Staloral

Intervention Description

Sublingual immunotherapy with Staloral dust mites solution

Primary Outcome Measure Information:

Title

determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo

Time Frame

September 2009

Secondary Outcome Measure Information:

Title

Time Frame

September 2009

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female outpatients aged 16 to 50 years (inclusive). House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year. 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 Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and < 1,000 µg equivalent budesonide/day. Exclusion Criteria: Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1). Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide. FEV1 < 70% of predicted value at Visit 1. 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 . 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia YIN, Pr.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital -

City

Beijing

ZIP/Postal Code

100029

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32926419

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.

Results Reference

derived

PubMed Identifier

26465232

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.

Results Reference

derived

PubMed Identifier

25056584

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.

Results Reference

derived

Learn more about this trial

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

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