A clinical trial to check efficacy and safety of house dust mite tablets in children and adolescents with allergic asthma

Phase 1

• Conditions: House Dust Mite (HDM) Allergic Asthma; MedDRA version: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-004363-39-DE
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-13
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

I1. Written informed consent obtained from parents/caregivers before any trial related procedures are performed. Consent or assent from the subject must be obtained according to national requirements. Footnote: At least one parent/caregiver must be able to read.
I2. Male or female of any race/ethnicity aged =4 to =17 years on the day informed consent is obtained from the parent/caregiver. The subject must be =5 to =17 years old at the randomisation visit
I3. A female subject of childbearing potential must have a negative pregnancy test and be willing to practise appropriate contraceptive methods until the follow-up TC
I4. A clinical history of HDM allergic asthma of at least 1 year duration diagnosed by a physician
I5. 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 within the past year prior to randomisation. For definition of ICS doses, please see Table 3 and Table 4
I6. =3 clinically relevant asthma exacerbations in the past two years or =2 clinically relevant asthma exacerbations in the past year or =1 severe asthma exacerbation in the past year prior to randomization while being on asthma controller medication (low dose ICS plus LABA or medium/high dose ICS with or without LABA) . The asthma controller medication at the screening visit must be at a dose equivalent to or below the dose the subject received before the last asthma exacerbation occurred
I7. One or more of the following within the past 4 weeks prior to randomisation:
a. Daytime asthma symptoms more than twice/week
b. Any nocturnal awakening due to asthma which require use of SABA rescue medication
c. SABA rescue medication needed for treatment of asthma symptoms more than twice/week
d. Any activity limitation due to asthma
I8. Lung function measured by FEV1 = 70% of predicted value or according to local requirements while on background treatment following at least a 6-hour washout of SABA at screening and randomisation
I9. Clinical history of HDM AR within the last year prior to randomisation
I10. An average TCRS>0 during the baseline period (period 2)
I11. Positive specific IgE (defined as =class 2, =0.70 kU/l) against D. pteronyssinus and/or D. farinae at screening
I12. Positive SPT to D. pteronyssinus and/or D. farinae at screening
I13. Subject willing and able to comply with trial protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

E1. Has a clinically relevant history and is sensitised, symptomatic and regularly exposed to animal dander, molds, and/or cockroach (e.g., present in the home, job, school, etc.) or other perennial allergen
E2. Has experienced a life-threatening asthma attack defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilator support
E3. 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
E4. 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
E5. SLIT treatment with D. pteronyssinus or D. farinae for more than 1 month within the last 5 years. In addition, any SLIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
E6. SCIT treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months
E7. Ongoing treatment with any allergy immunotherapy product
E8. Severe chronic oral inflammation
E9. Any nasal or naso/oropharyngeal condition that could confound the efficacy or safety assessments (e.g., hypertrophy of the pharyngeal/palatine tonsils, clinically relevant nasal polyps, a history of paranasal sinus surgery or surgery of nasal turbinates)
E10. Any clinically relevant chronic disease incl. malignancy that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subject
E11. Has a diagnosis or history of eosinophilic oesophagitis
E12. A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
E13. Active or poorly controlled autoimmune diseases, immune defects, immunodeficiencies, immunosuppression or malignant neoplastic diseases with current disease relevance
E14. Ongoing treatment with OCS
E15. Treatment with restricted and prohibited concomitant medication listed in Table 2
E16. Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
E17. 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
E18. A business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial
E19. A history of alcohol or drug abuse
E20. 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
E21. 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 wit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified