Efficacy of ALK house dust mite allergy immunotherapy tablet in subjects with house dust mite induced asthma. - The MITRA trial.
- Conditions
- House dust mite induced asthmaMedDRA version: 12.1 Level: LLT Classification code 10001705 Term: Allergic asthma
- Registration Number
- EUCTR2010-018621-19-GB
- Lead Sponsor
- ALK-Abello A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects who meet each of the following criteria are eligible for the trial:
1. Written informed consent obtained before entering the trial.
2. Male or female = 18 years.
3. A clinical relevant history consistent with HDM induced asthma of at least 1 year prior to trial entry.
4. Use of asthma medication (e.g. combination products) for the control of asthma symptoms for a period of at least 6 months within the past year.
5. Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg.
6. Documented reversible airway obstruction as judged by one of the following criteria:
a) Improvement in absolute FEV1 = 12% and 200 ml after administration of SABA.
b) Improvement in PEF > 20% after administration of SABA.
c) Diurnal variability in PEF > 20% after administration of SABA.
d) Bronchial provocation test:
1. A decrease in FEV1 > 15% after 6 min of sustained exercise.
2. A decrease in FEV1 = 10% from baseline is recorded after a 6 minutes period of hyperpnea in dry air.
3. A decrease in FEV1 = 15% from baseline or = 10% from value obtained after the previous dose after mannitol inhalation challenge.
4. A decrease in FEV1 = 20% from baseline after methacholine inhalation challenge.
7. Asthma control level above or equal to 1.0 (ACQ = 1.0) at visit 1 (screening).
8. Asthma control level between 1.0 and 1.5 (1.0 = ACQ = 1.5) at visit 3 (randomisation).
9. Electronic diary compliance rate between visit 2 and visit 3 = 80% at visit 3 (randomisation).
10. FEV1 > 60% of predicted value.
11. A clinical history consistent with mild to severe HDM induced allergic rhinitis for at least 1 year.
12. Positive SPT response (wheal diameter = 3 mm larger than the negative control) to Der pte or Der far.
13. Positive specific IgE against Der pte or Der far (= IgE Class 2; = 0.70 KU/L).
14. Female subjects, who are fertile must have a negative pregnancy test and be willing to practise appropriate contraceptive methods throughout the trial.
15. Subject willing and able to comply with trial protocol regimens.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects who meet one or more of the following criteria are excluded from the trial:
1. A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except HDM).
2. A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period of the year corresponding the ICS reduction period (period 3).
3. Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
4. A clinical history of chronic sinusitis (> 3 months).
5. Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
6. Current or previous use of any medication as specified in the protocol.
7. Symptoms of or treatment for upper respiratory tract infection, or other relevant infectious process at randomisation.
8. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis at randomisation.
9. Physical examination with clinically relevant findings.
10. History of systemic allergic reaction with cardiorespiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction).
11. History of recurrent urticaria during the last 2 years.
12. A history of drug induced (incl. immunotherapy) facial angioedema or a family (parents or siblings) history of hereditary angioedema.
13. Any clinically relevant chronic disease (= 3 months duration) (e.g. cystic fibrosis, malignancy, type I diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency).
14. Systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease, or immune deficiency disease).
15. Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit (except steroids for allergy and asthma symptoms).
16. History of allergy, hypersensitivity or intolerance to IMPs (except Der pte or Der far) or symptomatic medications.
17. Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to evaluate the efficacy of the the house dust mite Allergy Immunotherapy Tablet (6 DU and 12 DU) given once daily compared to placebo in subjects with house dust mite induced asthma, as measured by reducing the risk for an asthma exacerbation.;Primary end point(s): The primary endpoint is the time to first moderate or severe asthma exacerbation during period 3 (inhaled glucocorticosteroid reduction).;<br> Secondary Objective: The key secondary objectives of the trial are to determine the effects of the house dust mite Allergy Immunotherapy Tablet on asthma symptoms and immunology.<br><br> Other secondary objectives include evaluating the effects of the house dust mite Allergy Immunotherapy Tablet on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics.<br>
- Secondary Outcome Measures
Name Time Method