Back to resultsHouse Dust Mite SLIT in Elderly Patients
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
immunotherapy Staloral
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring immunotherapy, elderly
Eligibility 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.
Sites / Locations
- Allergology Outpatient Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
non immunotherapy treatment
sublingual immunotherapy course
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse event during immunotherapy
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
Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).
Full Information
NCT ID
NCT01605760
First Posted
May 17, 2012
Last Updated
May 21, 2012
Sponsor
Medical University of Silesia
1. Study Identification
Unique Protocol Identification Number
NCT01605760
Brief Title
House Dust Mite SLIT in Elderly Patients
Official Title
House Dust Mite Sublingual Immunotherapy: a Double-blind, Placebo Control Study in Elderly Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
immunotherapy, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non immunotherapy treatment
Arm Type
No Intervention
Arm Title
sublingual immunotherapy course
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
immunotherapy Staloral
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with adverse event during immunotherapy
Description
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.
Time Frame
three year
Secondary Outcome Measure Information:
Title
Change from baseline of nasal symptoms after immunotherapy
Description
Assessment of reducing the need for symptom-targeted drugs, primarily antihistamines and reducing of nasal symptoms during treatment in study patients (diary monitoring).
Time Frame
three year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Allergology Outpatient Clinic
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28668244
Citation
Bozek A, Starczewska-Dymek L, Jarzab J. Prolonged effect of allergen sublingual immunotherapy for house dust mites in elderly patients. Ann Allergy Asthma Immunol. 2017 Jul;119(1):77-82. doi: 10.1016/j.anai.2017.05.012.
Results Reference
derived
PubMed Identifier
23331565
Citation
Bozek A, Ignasiak B, Filipowska B, Jarzab J. House dust mite sublingual immunotherapy: a double-blind, placebo-controlled study in elderly patients with allergic rhinitis. Clin Exp Allergy. 2013 Feb;43(2):242-8. doi: 10.1111/cea.12039.
Results Reference
derived
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House Dust Mite SLIT in Elderly Patients
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