Asthma
Conditions
Keywords
HDM, AIT, asthma, asthma exacerbation, House dust mite induced asthma
Brief summary
The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.
Interventions
DRUGALK HDM AIT Placebo
Oral lyophilisate, Placebo, to be administered sublingually once daily
DRUGALK HDM AIT 6 DU
Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
DRUGALK HDM AIT 12 DU
Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
Sponsors
Ergomed
ACM Pivotal Global Central Laboratory
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * A clinical relevant history consistent with house dust mite induced asthma of at least 1 year prior to trial entry. * Use of an appropriate amount of inhaled corticosteroid for the control of asthma symptoms. * Documented reversible airway obstruction. * Suitable level of asthma control. * FEV1 ≥ 70% of predicted value. * Positive Skin Prick Test response to Der pte and/or Der far. * Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L). Key
Exclusion criteria
* A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites). * A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period from October to March. * Any clinically relevant chronic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first moderate or severe asthma exacerbation after ICS reduction | Measured during the last 6 months of the trial |
Secondary
| Measure | Time frame |
|---|---|
| Time to first severe asthma exacerbation after ICS reduction | Measured during the last 6 months of the trial |
| Frequency of asthma exacerbations following ICS reduction | Measured during the last 6 months of the trial |
| Difference in changes in immunological parameters (IgE, IgG4) | Measured at the end of the trial |
| Symptom free days | Measured during the last 6 months of the trial |
| Number and percentage of subjects with treatment emergent AEs | At end of trial |
| The average overall symptom score. | Measured during the last 6 months of the trial |
Countries
Germany
Outcome results
None listed