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NCT03654976 | COMPLETED | Allergic Asthma Due to Dermatophagoides Farinae

Mite Asthma Pediatric Immunotherapy Trial
Sponsor:

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

Allergic Asthma Due to Dermatophagoides Flour

Allergic Asthma Due to Dermatophagoides Pteronyssinus

Allergic Rhinitis Due to House Dust Mite

Intervention/treatment

HDM SLIT-tablet

Placebo

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 533 participants
Masking : QUADRUPLE
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 : 2018-02-22
Estimated Primary Completion Date : 2022-05-18
Estimated Study Completion Date : 2022-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Mite Asthma Pediatric Immunotherapy Trial

Location Details

NCT03654976

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

Miami Clinical Research

Miami, florida, United States, 33155

Not yet recruiting

United States, Georgia

Columbus Regional Research Institute

Columbus, Georgia, United States, 31904

Not yet recruiting

United States, road cancer

Respiratory Medicine Research Institute of MI

Ypsilanti, road cancer, United States, 48197

Not yet recruiting

United States, Pennsylvania

Private Clinic

Bangor, Pennsylvania, United States, 04401

Not yet recruiting

United States, Pennsylvania

Allergy Consultants

Verona, Pennsylvania, United States, 07044

Not yet recruiting

United States, Texas

TTS research

Boerne, Texas, United States, 78006

Not yet recruiting

United States, Texas

STAAMP Research

Saint Anthony, Texas, United States, 78251

Not yet recruiting

Bulgaria,

MATT

Plovdiv, Bulgaria,

Not yet recruiting

Bulgaria,

UMBAL "St. Georgy"

Plovdiv, Bulgaria,

Not yet recruiting

Bulgaria,

SHATPPD

Ruse, Bulgaria,

Not yet recruiting

Bulgaria,

Medical Center-1-Sevlievo EOOD

Sevlievo, Bulgaria,

Not yet recruiting

Bulgaria,

Other-Med-Medical Center EOOD

Sofia, Bulgaria,

Not yet recruiting

Bulgaria,

MBAL Tokuda Hospital Sofia

Sofia, Bulgaria,

Not yet recruiting

Bulgaria,

Medical Center Excelsior

Sofia, Bulgaria,

Not yet recruiting

Bulgaria,

December 2010

Stara Zagora, Bulgaria,

Not yet recruiting

France,

Augustin Morvan Hospital

Brest, France,

Not yet recruiting

France,

Caen University Hospital Center

Caen, France,

Not yet recruiting

France,

Intercommunal hospital center

Creteil, France,

Not yet recruiting

France,

Jeanne de Flandre Hospital

Little Cedex, France,

Not yet recruiting

France,

Armand Trousseau Hospital Group - La Roche Guyon

Paris, France,

Not yet recruiting

Germany,

Bramsche pediatrician practice

Bramsche, Germany,

Not yet recruiting

Germany,

Pediatric practice Ludwigsfelde

Ludwigsfelde, Germany,

Not yet recruiting

Germany,

Pediatrician's office

Wuppertal, Germany,

Not yet recruiting

Hungary,

St. Rókus Hospital in Baja

Baja, Hungary,

Not yet recruiting

Hungary,

Heim Pal Children's Hospital

Budapest, Hungary,

Not yet recruiting

Hungary,

Semmelweis University

Budapest, Hungary,

Not yet recruiting

Hungary,

Kanizsai Dorottya Korhaz

Grandmother, Hungary,

Not yet recruiting

Hungary,

Szent István Pharmacy and Pharmacy

Crayfish, Hungary,

Not yet recruiting

Hungary,

Aranyklinika Kft

Szeged, Hungary,

Not yet recruiting

Poland,

NZOZ E-Life

Białystok, Poland,

Not yet recruiting

Poland,

Private Medical Practice Pediatric and Allergological Office

Białystok, Poland,

Not yet recruiting

Poland,

Specialized Medical Practice

Katowice, Poland,

Not yet recruiting

Poland,

PROMED Medical Center

Krakow, Poland,

Not yet recruiting

Poland,

Center for Modern Therapies

Cracow, Poland,

Not yet recruiting

Poland,

ALERGOTEST s.c. Specialized Medical Center

Lublin, Poland,

Not yet recruiting

Poland,

University Children's Hospital in Lublin

Lublin, Poland,

Not yet recruiting

Poland,

Ostrowiec Medical Center S.C.

Ostrowiec Świętokrzyski, Poland,

Not yet recruiting

Poland,

Private Medical Office

Rzeszów, Poland,

Not yet recruiting

Poland,

NSZOZ Puls

Skarżysko-Kamienna, Poland,

Not yet recruiting

Poland,

ETG Skierniewice

Skierniewice, Poland,

Not yet recruiting

Poland,

ALERGO-MED Specialist

Tarnów, Poland,

Not yet recruiting

Poland,

Well-being

Wrocław, Poland,

Not yet recruiting

Poland,

Specialist.

Zabrze, Poland,

Not yet recruiting

Poland,

WWCOiT

Łódź, Poland,

Not yet recruiting

Russian Federation,

Kazan State Medical University 138

Kazan, Russian Federation,

Not yet recruiting

Russian Federation,

First Moscow State Medical University

Moscow, Russian Federation,

Not yet recruiting

Russian Federation,

Clinical and Diagnostic Centre "Zdorovie"

Rostov-on-Don, Russian Federation,

Not yet recruiting

Russian Federation,

Rayzan Regional Children Hospital

Ryazan, Russian Federation,

Not yet recruiting

Russian Federation,

LLC Kurator

Saint Petersburg, Russian Federation,

Not yet recruiting

Russian Federation,

City children's polyclinic #35

Saint-Petersburg, Russian Federation,

Not yet recruiting

Russian Federation,

GBUZ "Children Municipal Polyclinic #45"

Saint-Petersburg, Russian Federation,

Not yet recruiting

Russian Federation,

LC Arsvite North-West

Saint-Petersburg, Russian Federation,

Not yet recruiting

Russian Federation,

GBUZ "Samara Regional Children's Sanatorium "Yunost" 9-clearing

Samara, Russian Federation,

Not yet recruiting

Russian Federation,

LLC 'ArsVitae Samara'

Samara, Russian Federation,

Not yet recruiting

Russian Federation,

Siberian State Medical University

Tomsk, Russian Federation,

Not yet recruiting

Spain,

Germans Trias i Pujol University Hospital

Badalona, Spain,

Not yet recruiting

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain,

Not yet recruiting

Spain,

Regional University Hospital of Malaga

Málaga, Spain,

Not yet recruiting

Spain,

Sagunto Hospital

Sagunto, Spain,

Not yet recruiting

Spain,

Marqués de Valdecilla University Hospital

Santander, Spain,

Not yet recruiting

Spain,

Conxo Hospital

Santiago de Compostela, Spain,

Not yet recruiting

Spain,

Hospital de la Plana

Villarreal, Spain,

Not yet recruiting

United Kingdom,

Royal Manchester Children's Hospital - Paediatrics Oxford Road

Manchester, United Kingdom,

Not yet recruiting

United Kingdom,

Southampton General Hospital

Southampton, United Kingdom,