NCT00660452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

April 15, 2008

Last Update Submit

October 10, 2011

Conditions

Allergy

Keywords

AllergySLITAsthmaHouse Dust Mites

Outcome Measures

Primary Outcomes (1)

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

    September 2009

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Staloral

2

PLACEBO COMPARATOR

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

Drug: Staloral

Interventions

StaloralDRUG

Sublingual immunotherapy with Staloral dust mites solution

12

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital -

Beijing, 100029, China

Location

Related Publications (3)

  • 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.

    PMID: 32926419DERIVED

  • 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.

    PMID: 26465232DERIVED

  • 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.

    PMID: 25056584DERIVED

MeSH Terms

Conditions

HypersensitivityAsthma

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Study Officials

  • Jia YIN, Pr.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

CN(1)