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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

300 IR house dust mites allergen extract tablet

500 IR house dust mites allergen extract tablet

Placebo tablet

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring House dust mites allergy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

300 IR

500 IR

Placebo

Arm Description

300 IR house dust mites allergen extract tablet

500 IR house dust mites allergen extract tablet

Placebo tablet

Outcomes

Primary Outcome Measures

Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period

The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12, the higher the score the more severe the rhinitis.

Secondary Outcome Measures

Average Rhinitis Total Symptom Score (ARTSS)

The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.

Full Information

NCT ID

NCT00674700

First Posted

May 6, 2008

Last Updated

April 12, 2016

Sponsor

Stallergenes Greer

1. Study Identification

Unique Protocol Identification Number

NCT00674700

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stallergenes Greer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

House dust mites allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

509 (Actual)

8. Arms, Groups, and Interventions

Arm Title

300 IR

Arm Type

Active Comparator

Arm Description

300 IR house dust mites allergen extract tablet

Arm Title

500 IR

Arm Type

Active Comparator

Arm Description

500 IR house dust mites allergen extract tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet

Intervention Type

Drug

Intervention Name(s)

300 IR house dust mites allergen extract tablet

Other Intervention Name(s)

Sublingual immunotherapy tablet

Intervention Description

One sublingual tablet daily for one year

Intervention Type

Drug

Intervention Name(s)

500 IR house dust mites allergen extract tablet

Other Intervention Name(s)

Sublingual immunotherapy tablet

Intervention Description

One sublingual tablet daily for one year

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Other Intervention Name(s)

Sublingual placebo tablet

Intervention Description

One sublingual tablet daily for one year

Primary Outcome Measure Information:

Title

Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period

Description

Time Frame

Last 3 months of Year 1

Secondary Outcome Measure Information:

Title

Average Rhinitis Total Symptom Score (ARTSS)

Description

Time Frame

Last 3 months of Year 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl-Christian BERGMANN, MD

Organizational Affiliation

Allergie-Centrum-Charité / ECARF

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

24388010

Citation

Bergmann KC, Demoly P, Worm M, Fokkens WJ, Carrillo T, Tabar AI, Nguyen H, Montagut A, Zeldin RK. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.

Results Reference

result

PubMed Identifier

22994348

Citation

Baron-Bodo V, Batard T, Nguyen H, Frereux M, Horiot S, Harwanegg C, Bergmann KC, de Beaumont O, Moingeon P. Absence of IgE neosensitization in house dust mite allergic patients following sublingual immunotherapy. Clin Exp Allergy. 2012 Oct;42(10):1510-8. doi: 10.1111/j.1365-2222.2012.04044.x.

Results Reference

derived

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

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