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House Dust Mite Injection Immunotherapy in Elderly Patients. (HDMeld)

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ClinicalTrials.gov Identifier: NCT03209245
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Andrzej Bozek, Medical University of Silesia

Brief Summary:

Background. Immunotherapy in elderly patients is controversial, and there is still not much evidences supporting this treatment's safety and efficacy in this population. This study was performed to evaluate the safety and efficacy of specific injection immunotherapy for house dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means in the label in comparison to placebo.

Materials and methods. The study with double blind, placebo controlled trial was conducted in one centre. Fifty eight elderly patients with house dust mites allergy and AR were individually randomized in comparable numbers to one of two parallel groups: two years perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der p1 and Der p2 were monitoring.


Condition or disease Intervention/treatment Phase
Allergen Immunotherapy in Elderly Patients Biological: Purethal Mites Other: placebo injection Diagnostic Test: monitoring of allergen specific IgE Diagnostic Test: monitoring of allergen specific IgG4 Phase 3

Detailed Description:
The aim of this study was to assess the safety and efficacy of injection AIT for HDM allergens in elderly patients with allergic rhinitis and a confirmed HDM allergy. The study with double blind, placebo controlled trial was conducted in one centre. A total of 92 patients ranging from 65 to 73 years of age were recruited from the outpatient allergy clinic to assess their eligibility for inclusion in the study. First, there was a need for pre screening approximately 157 patients with inhalant allergies and the right age. Additionally, the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens. Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens (including other pollens) were excluded from the study. A careful examination of the eyes, ears, nose, and throat was performed on all patients. The severity of perennial allergic rhinitis (AR) was assessed using the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. The patients were randomly selected to receive PURETHAL Mites (20,000 AUeq/ml, HAL Allergy BV, Leiden, The Netherlands, containing major allergen equivalents of 14.0 μg/ml group 1, and 20.0 μg/ml group 2, measured by ELISA in the extract prior to modification and adsorption on aluminium hydroxide) or a placebo (Figure 1). The recruitment period was limited to three months (April-June). Purethal Mites were administered as perennial therapy using the following regimen: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treatment of AIT- active group
Masking: Single (Investigator)
Masking Description: Treatment with placebo - placebo groub
Primary Purpose: Treatment
Official Title: House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.
Actual Study Start Date : April 10, 2014
Actual Primary Completion Date : June 20, 2016
Actual Study Completion Date : April 15, 2017

Arm Intervention/treatment
Active Comparator: Active AIT group

Injection immunotherapy with Purethal Mites were administered as perennial therapy using the following regimen of injections: 1 dose- 0.1 ml, 2 doses - 0.2 ml, 3 doses - 0.5 ml every week, and 0.5 ml every four weeks during 24 months.

monitoring of allergen specific IgE monitoring of allergen specific IgG4

Biological: Purethal Mites
perennial allergren specific immunotherapy during 24 months

Diagnostic Test: monitoring of allergen specific IgE
measurement the serum specific IgE at the start and at the end of trial

Diagnostic Test: monitoring of allergen specific IgG4
measurement the serum specific IgG4 at the start and at the end of trial

Placebo Comparator: non-active, placebo treatment
symptomatic treatment with concomitant use of placebo injection monitoring of allergen specific IgE monitoring of allergen specific IgG4
Other: placebo injection
perrenial injection wich were administered in same protocol as Purethal

Diagnostic Test: monitoring of allergen specific IgE
measurement the serum specific IgE at the start and at the end of trial

Diagnostic Test: monitoring of allergen specific IgG4
measurement the serum specific IgG4 at the start and at the end of trial




Primary Outcome Measures :
  1. The primary endpoint was the change from baseline in the mean AAdSS score difference in comparison to placebo. [ Time Frame: baseline and 24 months ]
    Symptoms and medication score were presented as the average adjusted symptom score (AAdSS): score result with standard deviation


Secondary Outcome Measures :
  1. Patients' quality of life was evaluated with the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score [ Time Frame: baseline, after 12 months and 24 months of study ]
    fill the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - score result


Other Outcome Measures:
  1. The serum-specific IgE, IgG and IgG4 levels to HDM (D. pteronyssinus, D. farinae) and to Der p1 and Der p2 were determined [ Time Frame: baseline and 24 months ]
    ELISA test results in IU/L



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subjects had moderate or severe intermittent allergic rhinitis and fulfilled the Allergic Rhinitis and its Impact on Asthma (ARIA) criterion
  • the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens.

Exclusion Criteria:

  • Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens were excluded from the study. Additionally, patients with any of the following characteristics were also excluded: diagnosis of bronchial asthma, non-allergic rhinitis and severe non-stable diseases. Patients with other nasal problems, such as chronic nasal obstruction, reduced olfaction, bacterial colonization, and chronic sinusitis, were diagnosed based on a CT scan and nasal endoscopy were excluded. Subjects with other chronic or acute clinical disorders or with a history of respiratory tract infections within four weeks of the study initiation were also excluded.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrzej Bozek, Clinical Professor Andrzej Bozek, MD, PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03209245     History of Changes
Other Study ID Numbers: HAB605060182
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs