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House Dust Mite SLIT in Elderly Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrzej Bozek, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT01605760
First received: May 17, 2012
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick tests, serum-specific IgE and nasal provocation tests were included. Patients were individually randomised to groups: active or placebo using a double-blind method. A total of 51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R, Stallergens, France) and 57 in the placebo group were monitored for three years. The patients had to record on a diary card whenever they used anti-allergic medications.


Condition Intervention Phase
Allergic Rhinitis
 Drug: immunotherapy Staloral
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.

Further study details as provided by Medical University of Silesia:

Primary Outcome Measures:
  • Number of participants with adverse event during immunotherapy [ Time Frame: three year ] [ Designated as safety issue: Yes ]
    Safety assessment of sublingual immunotherapy on the basis of the monitoring clinical adverse events during treatment by the use of a patient diary and medical examination.


Secondary Outcome Measures:
  • Change from baseline of nasal symptoms after immunotherapy [ Time Frame: three year ] [ Designated as safety issue: No ]
    Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).


Enrollment: 111
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: non immunotherapy treatment Drug: immunotherapy Staloral
Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
Active Comparator: sublingual immunotherapy course Drug: immunotherapy Staloral
Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with allergic rhinitis who fulfilled the ARIA criterion and had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE) and had positive nasal provocation tests (NPTs) by Dermatophagoides pteronyssinus (Der p) and Dermatophagoides farinae (Der f) were included in the study

Exclusion Criteria:

  • Patients with any of the following characteristics were excluded:

    • hypersensitivity to other allergens,
    • non-allergic rhinitis (especially senile or vasomotor rhinitis) or
    • severe non-stable diseases (especially bronchial asthma). However, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605760

Locations
Poland
Allergology Outpatient Clinic
Zabrze, Poland, 41-800
Sponsors and Collaborators
Medical University of Silesia
  More Information

No publications provided

Responsible Party: Andrzej Bozek, Medical Doctor, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT01605760     History of Changes
Other Study ID Numbers: 657898/2008
Study First Received: May 17, 2012
Last Updated: May 21, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Silesia:
immunotherapy
elderly

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013