Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
1 other identifier
interventional
94
1 country
1
Brief Summary
The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started May 2012
Longer than P75 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 1, 2014
June 1, 2014
2.1 years
May 25, 2012
June 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
10 dosing days
Study Arms (2)
SLIT tablets of HDM allergen extracts
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
10 dosing days
Eligibility Criteria
You may qualify if:
- Written informed consent.
- Male or female patient from 18 to 50 years.
- Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
- Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
- Stable asthma treatments.
- Spirometry with best FEV1 \> 70% of the predicted value.
- Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
- Asthma Control Test™ (ACT) score ≥ 20.
You may not qualify if:
- Current smoker or former smoker with \> 10 pack/year history.
- Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
- Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
- Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
- Female patient pregnant or breast-feeding/lactating.
- Female patient of childbearing potential not using a medically accepted contraceptive method.
- Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- Patient who received allergen immunotherapy for HDM in the last 10 years.
- Ongoing treatment by immunotherapy with another allergen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Arnaud de Villeneuve
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascal Demoly, MD
CHU Arnaud de Villeneuve, Montpellier, France
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2012
First Posted
May 31, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 1, 2014
Record last verified: 2014-06