Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 30 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

Mite Asthma Pediatric Immunotherapy Trial (MAPIT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03654976
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief Summary:
The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Condition or disease Intervention/treatment Phase
Allergic Asthma Due to Dermatophagoides Farinae Allergic Asthma Due to Dermatophagoides Pteronyssinus Allergic Rhinitis Due to House Dust Mite Biological: HDM SLIT-tablet Other: Placebo Phase 3

Detailed Description:

The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with HDM allergic asthma based on clinically relevant asthma exacerbations.

Additionally, the trial will investigate if the treatment has an effect on asthma symptoms including nightly awakenings due to asthma, asthma medication use, asthma control, lung function, allergic rhinitis and allergic rhinoconjunctivitis.

Finally, quality of life (QoL) for subjects and caregivers will be measured.

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 2 years. Subjects will receive a written asthma action plan.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Children and Adolescents (5-17 Years) With HDM Allergic Asthma
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: Active treatment
Subject's ICS or ICS/LABA background medication plus HDM SLIT-tablet
Biological: HDM SLIT-tablet
Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
Other Names:
  • Acarizax
  • Odactra

Placebo Comparator: Placebo
Subject's ICS or ICS/LABA background medication plus placebo oral tablet
Other: Placebo
Placebo sublingual tablet, for daily administration (1 tablet per day)




Primary Outcome Measures :
  1. Clinically relevant asthma exacerbations [ Time Frame: Through study completion, approximately 24 months ]
    Annualised rate of clinically relevant asthma exacerbations


Secondary Outcome Measures :
  1. Nightly awakenings [ Time Frame: Through study completion, approximately 24 months ]
    Proportion of days with nocturnal awakenings due to asthma requiring SABA duing eDiary recording

  2. SABA use [ Time Frame: Through study completion, approximately 24 months ]
    Average daily dose of SABA during eDiary recording

  3. Lung function [ Time Frame: Through study completion, approximately 24 months ]
    Percentage predicted FEV1


Other Outcome Measures:
  1. Allergic rhinitis symptoms [ Time Frame: Through study completion, approximately 24 months ]
    Rhinitis symptoms

  2. Allergic rhinitis medication use [ Time Frame: Through study completion, approximately 24 months ]
    Symptomatic medication use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Male or female of any race/ethnicity aged 5-17 years
  • A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods
  • A clinical history of HDM allergic asthma
  • Use of low daily dose of ICS plus LABA or medium/high daily dose of ICS with or without LABA for the control of asthma symptoms
  • A clinical history of asthma exacerbations in the past two years
  • One or more of the following within the past 4 weeks prior to randomisation:

    • Daytime asthma symptoms more than twice/week
    • Any nocturnal awakening due to asthma
    • SABA rescue medication needed for treatment of asthma symptoms
    • Any activity limitation due to asthma
  • Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements
  • Clinical history of HDM AR within the last year prior to randomisation
  • An average TCRS>0 during the baseline period
  • Positive specific IgE (defined as ≥class 2, ≥0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
  • Positive SPT to D. pteronyssinus and/or D. farinae at screening
  • Subject willing and able to comply with trial protocol

Exclusion Criteria:

  • Is sensitised and regularly exposed to animal dander, molds, and/or cockroach or other perennial allergen
  • Has experienced a life-threatening asthma attack
  • Within the last month before the randomisation visit (visit 3), has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
  • Within the last 3 months before the randomisation visit (visit 3) while on high dose ICS treatment, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids
  • Any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
  • Ongoing treatment with any allergy immunotherapy product
  • Any clinically relevant condition or chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
  • Has a diagnosis of eosinophilic oesophagitis
  • A relevant history of systemic allergic reactions
  • Ongoing treatment with OCS
  • Treatment with restricted and prohibited concomitant medication
  • Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
  • A history of allergy, hypersensitivity or intolerance to any of the excipients or active substance of the IMP (except D. pteronyssinus and D. farinae) or to any excipient of the rescue medication provided in this trial
  • A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
  • A history of alcohol or drug abuse
  • Has previously been randomised into this trial, is participating in this trial at another investigational site or is participating or planning to participate in any other clinical trial during the duration of this trial
  • Has a history or current evidence of any condition, treatment, laboratory values out of range or other circumstance that in the opinion of the investigator are clinically relevant and might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial
  • Has a condition or treatment that increase the risk of the subject developing severe adverse reactions after adrenaline/epinephrine administration
  • Is unable to or will not comply with the use of adrenaline/epinephrine auto-injectors for countries where this is a regulatory requirement

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): NCT03654976


Contacts
Layout table for location contacts
Contact: Bente Riis, PhD +45 4574 7576 clinicaltrials@alk.net
Contact: Martin R Pedersen, MSc +45 4574 7576 clinicaltrials@alk.net

Locations
Layout table for location information
Hungary
Aranyklinika Kft Recruiting
Szeged, Hungary
Contact: Novak, MD         
Poland
Ostrowieckie Centrum Medyczne S.C. Recruiting
Ostrowiec Świętokrzyski, Poland
Contact: Olech-Cudzik, MD         
United Kingdom
Southampton General Hospital Recruiting
Southampton, United Kingdom
Contact: Roberts, MD         
Sponsors and Collaborators
ALK-Abelló A/S

Layout table for additonal information
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT03654976     History of Changes
Other Study ID Numbers: MT-11
2016-004363-39 ( EudraCT Number )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 asthma, allergic rhinitis, HDM, pediatric

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases