Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis - Full Text View

Sponsored by:	Stallergenes
Information provided by:	Stallergenes
ClinicalTrials.gov Identifier:	NCT00674700

Purpose

The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract Drug: placebo	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, DBPC, Multi-National Phase II/III Study of the Safety and Efficacy of Two Doses of Sublingual Immunotherapy (SLIT) Administered as Allergen-Based Tablets Once Daily to Adult Patients Suffering From HDM Allergic Rhinitis

Further study details as provided by Stallergenes:

Primary Outcome Measures:

Evaluation of the Average Rhinitis Total Symptom Score (ARTSS) at endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average Rescue Medication Score, Average Combined Score, Five Individual Average Symptoms Score, Overall RQLQ , Global evaluation of efficacy by patient, Skin Prick Test, Immunological markers, Asthma status, Asthma Control Test Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	509
Study Start Date:	October 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: Active Comparator 162 active patients with house dust mites related allergic rhinitis receiving 300IR allergen- based tablets	Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract House dust mite allergen-based tablets, 300 IR, once daily, 12 months
A, 2: Active Comparator 162 active patients with house dust mite allergic rhinitis receiving 500 IR allergen-based tablets	Drug: Sublingual Immunotherapy Tablets of house dust mites allergen extract House dust mite allergen-based tablets, 500 IR, once daily, 12 months
A, 3: Placebo Comparator 162 patients with house dust mite allergic rhinitis receiving placebo tablets	Drug: placebo placebo tablets, once daily, 12 months

Detailed Description:

Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about 10 to 20% of the general population. House dust mite allergens are known to cause perennial allergic rhinitis.

In designing the present study, the guidelines proposed by the World Allergy Organization (WAO) task force for methodology of immunotherapy studies have been taken into consideration.

After a 2-month screening period, patients will be administered the dose of 300 IR- or 500 IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The carry-over effect will be evaluated after a treatment-free follow up period of 12 months.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients aged 18 to 50 years (inclusive).
Patients who have been informed of the nature and aims of the study and have given their written consent
Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.
Female patients of childbearing potential are eligible
Negative urine pregnancy test on female patients of childbearing potential.
House dust mite-related allergic rhinitis for at least 1 year.
Sensitised to D. pteronyssinus or D. farinae (positive SPT with wheal diameter greater than 3 mm and a specific IgE level ≥ 0.7 kU/L).
Baseline ARTSS > 5 (after completion of the 7-day daily record card).
Patients who are willing to comply with the protocol.
Patients who are able to understand the information given and the text of the consent form, and who are able to complete the daily record card and the RQLQ.

Exclusion Criteria:

Whatever the considered allergens, co-sensitisation leading to clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites).
Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).
Patients sensitised to cat or dog allergens and living with these animals at home.
Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
Asthma requiring treatment other than beta-2 inhaled agonists. Patients with intermittent asthma not necessitating inhaled or systemic corticoid treatment may be included (corresponding to the Global Initiative for Asthma [GINA] Step 1).
Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1.
Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2.
FEV1 < 80% of predicted value at Visit 1.
Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.
Patients at risk of non-compliance.
Participation in any clinical study within the 12 weeks before Visit 1.
Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
Any change in environmental measures for allergen avoidance during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674700

Sponsors and Collaborators

Stallergenes

Investigators

Study Chair:

Karl-Christian BERGMANN, MD

Allergie-Centrum-Charité / ECARF

More Information

Responsible Party:	STALLERGENES ( MELAC )
Study ID Numbers:	VO57.07
Study First Received:	May 6, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00674700
Health Authority:	France: Afssaps - French Health Products Safety Agency; Czech Republic: State Institute for Drug Control; Germany: Paul-Ehrlich-Institut; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; Spain: Ministry of Health and Consumption

Keywords provided by Stallergenes:

House dust mites allergy

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis

Additional relevant MeSH terms:

Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009