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

April 12, 2016 updated by: Stallergenes Greer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo tablet
One sublingual tablet daily for one year
Other Names:
  • Sublingual placebo tablet
Active Comparator: 300 IR
300 IR house dust mites allergen extract tablet
Drug: 300 IR house dust mites allergen extract tablet
One sublingual tablet daily for one year
Other Names:
  • Sublingual immunotherapy tablet
Active Comparator: 500 IR
500 IR house dust mites allergen extract tablet
Drug: 500 IR house dust mites allergen extract tablet
One sublingual tablet daily for one year
Other Names:
  • Sublingual immunotherapy tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period
Time Frame: Last 3 months of Year 1

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.
Last 3 months of Year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Rhinitis Total Symptom Score (ARTSS)
Time Frame: Last 3 months of Year 1
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.
Last 3 months of Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Investigators

  • Study Chair: Karl-Christian BERGMANN, MD, Allergie-Centrum-Charité / ECARF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VO57.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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