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

NCT00674700 | Completed Phase 2 Results

• 1 other identifier: VO57.07
• Study Type: interventional
• Target: 509
• Locations: 0 countries
• Sites: N/A

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

Conditions

Allergic Rhinitis

Keywords

House dust mites allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  Last 3 months of Year 1

Secondary Outcomes (1)

• Average Rhinitis Total Symptom Score (ARTSS)

  Last 3 months of Year 1

Study Arms (3)

300 IR

ACTIVE COMPARATOR

300 IR house dust mites allergen extract tablet

Drug: 300 IR house dust mites allergen extract tablet

500 IR

ACTIVE COMPARATOR

500 IR house dust mites allergen extract tablet

Drug: 500 IR house dust mites allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

300 IR house dust mites allergen extract tablet DRUG

One sublingual tablet daily for one year

Also known as: Sublingual immunotherapy tablet

300 IR

500 IR house dust mites allergen extract tablet DRUG

One sublingual tablet daily for one year

Also known as: Sublingual immunotherapy tablet

500 IR

Placebo tablet DRUG

One sublingual tablet daily for one year

Also known as: Sublingual placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stallergenes Greer: lead

Related Publications (3)

• 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.

  PMID: 24388010 RESULT

• Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

  PMID: 39035788 DERIVED

• 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.

  PMID: 22994348 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Michel Roux, Medical Director
• Organization: Stallergenes

mroux@stallergenes.com

+33 1 55 59 2970

Study Officials

• Karl-Christian BERGMANN, MD

  Allergie-Centrum-Charité / ECARF

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: May 19, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-04