Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
This study is currently recruiting participants.
Verified May 2012 by Stallergenes
Sponsor:
Stallergenes
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT01608243
First received: May 25, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma House Dust Mite Allergy |
Biological: SLIT tablets of house dust mite allergen extracts Biological: Matching placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Stallergenes:
Primary Outcome Measures:
- Safety, tolerability as indicated by adverse events and safety laboratory evaluation [ Time Frame: 10 dosing days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 64 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SLIT tablets of HDM allergen extracts |
Biological: SLIT tablets of house dust mite allergen extracts
10 dosing days
|
| Placebo Comparator: Placebo |
Biological: Matching placebo
10 dosing days
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608243
Contacts
| Contact: Martine LE GALL | +33 (0)1 55 59 20 00 | mlegall@stallergenes.com |
Locations
| France | |
| CHU Arnaud de Villeneuve | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Pascal Demoly, MD +33 (0)4 67 04 20 20 | |
Sponsors and Collaborators
Stallergenes
Investigators
| Principal Investigator: | Pascal Demoly, MD | CHU Arnaud de Villeneuve, Montpellier, France |
More Information
No publications provided
| Responsible Party: | Stallergenes |
| ClinicalTrials.gov Identifier: | NCT01608243 History of Changes |
| Other Study ID Numbers: | VO71.11 |
| Study First Received: | May 25, 2012 |
| Last Updated: | May 25, 2012 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013