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

July 5, 2017 updated by: Andrzej Bozek, Medical University of Silesia

House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Other: placebo injection
perrenial injection wich were administered in same protocol as Purethal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline, after 12 months and 24 months of study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Silesia

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HAB605060182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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