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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674700
• Other study ID #: VO57.07
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 6, 2008
• Last updated: December 20, 2011
• Start date: October 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2011
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Czech Republic: State Institute for Drug ControlGermany: Paul-Ehrlich-InstitutNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: February 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Male or female outpatients aged 18 to 50 years (inclusive).

2. Patients who have been informed of the nature and aims of the study and have given their written consent

3. Patients must be in general good health as determined by past medical history, physical examination and safety laboratory tests.

4. Female patients of childbearing potential are eligible

5. Negative urine pregnancy test on female patients of childbearing potential.

6. House dust mite-related allergic rhinitis for at least 1 year.

7. 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).

8. Baseline ARTSS > 5 (after completion of the 7-day daily record card).

9. Patients who are willing to comply with the protocol.

10. 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:

1. 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).

2. Patients with any nasal condition that could confound the efficacy or safety assessments (for example nasal polyposis).

3. Patients sensitised to cat or dog allergens and living with these animals at home.

4. Pregnant, breast-feeding / lactating or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.

5. 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).

6. Patients treated with systemic, nasal or inhaled steroids (whatever the indication) within 4 weeks before Visit 1.

7. Patients treated with long acting systemic steroids (whatever the indication) within 12 weeks before Visit 1 and before Visit 2.

8. FEV1 < 80% of predicted value at Visit 1.

9. Patients who received allergy specific immunotherapy for house dust mites in the last 10 years.

10. Patients at risk of non-compliance.

11. Participation in any clinical study within the 12 weeks before Visit 1.

12. Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.

13. Any change in environmental measures for allergen avoidance during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Sublingual Immunotherapy Tablets of house dust mites allergen extract
House dust mite allergen-based tablets, 300 IR, once daily, 12 months
• Sublingual Immunotherapy Tablets of house dust mites allergen extract
House dust mite allergen-based tablets, 500 IR, once daily, 12 months
• placebo
placebo tablets, once daily, 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Average Rhinitis Total Symptom Score (ARTSS) at endpoint		12 months	No
Secondary	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		12 months	No