NCT01608243CompletedPhase 1
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Stallergenes Greer
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Safety, tolerability as indicated by adverse events and safety laboratory evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
SLIT tablets of HDM allergen extracts
Experimental
Intervention: SLIT tablets of house dust mite allergen extracts (Biological)
Placebo
Placebo Comparator
Intervention: Matching placebo (Biological)
Outcomes
Primary Outcomes
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
Time Frame: 10 dosing days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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