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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 6, 2017
Actual Study Start Date  ICMJE April 10, 2014
Actual Primary Completion Date June 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE House Dust Mite Injection Immunotherapy in Elderly Patients.
Official Title  ICMJE House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Allergen Immunotherapy in Elderly Patients
Intervention  ICMJE
  • Biological: Purethal Mites
    perennial allergren specific immunotherapy during 24 months
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Biological: Purethal Mites
    • Diagnostic Test: monitoring of allergen specific IgE
    • Diagnostic Test: monitoring of allergen specific IgG4
  • Placebo Comparator: non-active, placebo treatment
    symptomatic treatment with concomitant use of placebo injection monitoring of allergen specific IgE monitoring of allergen specific IgG4
    Interventions:
    • Other: placebo injection
    • Diagnostic Test: monitoring of allergen specific IgE
    • Diagnostic Test: monitoring of allergen specific IgG4
Publications * Bożek A, Kołodziejczyk K, Kozłowska R, Canonica GW. Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial. Clin Transl Allergy. 2017 Dec 1;7:43. doi: 10.1186/s13601-017-0180-9. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2017
Actual Primary Completion Date June 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209245
Other Study ID Numbers  ICMJE HAB605060182
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andrzej Bozek, Medical University of Silesia
Study Sponsor  ICMJE Medical University of Silesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Silesia
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP