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Trial record 1 of 1 for:    NCT04145219
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Mite Allergy Trial In Children (MATIC)

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: NCT04145219
Recruitment Status : Active, not recruiting
First Posted : October 30, 2019
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief Summary:
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Dermatophagoides Farinae Allergic Rhinitis Due to Dermatophagoides Pteronyssinus Allergic Rhinitis Due to House Dust Mite Biological: Sublingual allergy immunotherapy tablet Other: Placebo Phase 3

Detailed Description:

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment.

In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL).

The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Actual Study Start Date : October 12, 2019
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: Active treatment
HDM SLIT-tablet plus allergy and asthma rescue medication
Biological: Sublingual allergy immunotherapy tablet
For daily administration (1 tablet per day)
Other Names:
  • Acarizax
  • Odactra

Placebo Comparator: Placebo
Placebo oral tablet plus allergy and asthma rescue medication
Other: Placebo
For daily administration (1 tablet per day)
Other Name: Placebo sublingual tablet




Primary Outcome Measures :
  1. Combined rhinitis symptoms and medication use [ Time Frame: The last 8 weeks of approximately 12 months of treatment ]
    The average daily sum of a rhinitis symptoms score and rhinitis medication score measured on a common scale


Secondary Outcome Measures :
  1. Rhinitis symptoms [ Time Frame: The last 8 weeks of approximately 12 months of treatment ]
    The average of a daily rhinitis symptoms score

  2. Rhinitis medication [ Time Frame: The last 8 weeks of approximately 12 months of treatment ]
    The average of a daily rhinitis medication score

  3. Combined rhinoconjunctivitis symptoms and medication use [ Time Frame: The last 8 weeks of approximately 12 months of treatment ]
    The average daily sum of a rhinoconjunctivitis symptoms score and rhinoconjunctivitis medication score measured on a common scale

  4. Safety and tolerability [ Time Frame: From first subject screened until last subject last visit ]
    Adverse events and assessment of lung function



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged 5-11 years
  • A clinical history of HDM AR/C (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
  • Have a certain level of AR symptoms on at least 8 of the last 14 days of the baseline period
  • Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
  • Positive skin prick test (SPT) and IgE to D. pteronyssinus or D. farinae at screening
  • Lung function ≥ 70% of predicted value

Exclusion Criteria:

  • Sensitised and regularly exposed to perennial allergens
  • Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
  • Asthma requiring treatment with high dose of inhaled corticosteroid
  • A relevant history of systemic allergic reaction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145219


Locations
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Sponsors and Collaborators
ALK-Abelló A/S
Investigators
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Principal Investigator: Antje Schuster, MD Professor of Pediatrics, Düsseldorf University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT04145219    
Other Study ID Numbers: MT-12
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALK-Abelló A/S:
Allergic rhinitis
HDM
pediatric
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases