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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00674700
First received: May 6, 2008
Last updated: April 12, 2016
Last verified: April 2016
  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: 300 IR house dust mites allergen extract tablet
Drug: 500 IR house dust mites allergen extract tablet
Drug: Placebo tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:
  • Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period [ Time Frame: Last 3 months of Year 1 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Last 3 months of Year 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 509
Study Start Date: October 2007
Study Completion Date: February 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sublingual immunotherapy tablet
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo tablet
One sublingual tablet daily for one year
Other Name: Sublingual placebo tablet

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   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00674700     History of Changes
Other Study ID Numbers: VO57.07 
Study First Received: May 6, 2008
Results First Received: January 25, 2016
Last Updated: April 12, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2016