E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
House dust mite induced allergic asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic asthma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of the ALK house dust mite (HDM) allergy immunotherapy tablet (AIT) (6 Development Unit (DU) and 12 DU) given once daily compared to placebo in subjects with HDM induced asthma, as measured by reducing the risk for an asthma exacerbation |
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E.2.2 | Secondary objectives of the trial |
To determine the effects of ALK HDM AIT on asthma symptoms and immunology.
To evaluate the effects of ALK HDM AIT on lung function, asthma control, safety, symptomatic medication, asthma quality of life, and pharmacoeconomics.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent obtained before entering the trial. Male or female ≥ 18 years. • A clinical relevant history consistent with HDM-induced asthma of at least 1 year prior to trial entry. • 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. • Dose of ICS after switching should at randomisation be in a range of budesonide 400-800 mcg. • Documented reversible airway obstruction. • Asthma control level above or equal to 1.0 (asthma control questionnaire (ACQ) ≥ 1.0) at visit 1 (screening). • Asthma control level between 1.0 and 1.5 (1.0 ≤ ACQ ≤ 1.5) at visit 3 (randomisation). Electronic diary compliance rate between visit 2 and visit 3 ≥ 80% at visit 3 (randomisation) • FEV1 > 60% of predicted value. • A clinical history consistent with HDM-induced allergic rhinitis for at least 1 year. • Positive SPT response (wheal diameter ≥ 3 mm larger than the negative control) to Der pte and/or Der far. • Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L). |
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E.4 | Principal exclusion criteria |
• A clinical history of persistent allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitized (except HDM). • 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) • Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years. • Hospitalisation for more than 12 hours due to asthma exacerbation within the last 3 months prior to screening visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the time to first asthma exacerbation during period 3 (ICS reduction).
Time to first asthma exacerbation is measured in days from start of period 3 (ICS reduction).
To fulfil the criteria for a moderate asthma exacerbation the subject must experience one or more of the following criteria leading to a change in treatment: a) Nocturnal awakening(s) due to asthma requiring short-acting β2-agonist (SABA) use for at least 2 consecutive nights or an increase of minimum 0.75 in daily symptom score from baseline value on at least 2 consecutive days. b) An increase from baseline value in occasions of SABA use on at least 2 consecutive days (a minimum increase of 4 puffs per day). c) ≥ 20% decrease in morning or evening peak expiratory flow (PEF) from baseline value on at least 2 consecutive days or ≥ 20% decrease in forced expiratory volume in one second (FEV1) from baseline value. d) Visit to the emergency room or unscheduled visit to the trial centre for asthma treatment not requiring systemic corticosteroids
The baseline value is the mean values during the last 14 days of the screening period.
If the subject experience one of the following events, this will be characterised as a severe asthma exacerbation: e) Need of systemic corticosteroids for treatment of asthma symptoms for at least 3 days. f) Emergency room visit because of asthma, requiring systemic corticosteroids or hospitalisation for more than 12 hours because of asthma.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the end of the trial is defined in the protocol as database closure |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |