E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IgE mediated House dust mite induced mild to moderate asthma and mild to severe allergic rhinitis. |
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MedDRA Classification |
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 specific immunotherapy with three dosages of the ALK HDM tablet given once daily compared to placebo in subjects suffering from house dust mite allergy. The evaluation is based on reduction in inhaled corticosteroid (ICS)
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy and safety of specific immunotherapy with three dosages of the ALK HDM tablet given once daily compared to placebo in subjects suffering from house dust mite allergy
The efficacy evaluations are based on: Asthma control (ACQ) and use of asthma rescue medication, rhinoconjunctivitis symptoms and use of rhinoconjunctivitis symptoms and use of rhinoconjunctivitis rescue medication, number of asthma exacerbation, quality of life, lung function, and new sensitivities.
The safety evaluations are based on Adverse Events(AEs), vital signs, haematology and clinical chemical analysis.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and females aged 14 years and above A clinical history of house dust mite induced mild to moderate persistent asthma of at least one year prior to trial entry. Use of an appropriate amount of inhaled corticosteroid (in accordance with the Gina Guidelines) for the control of the mild to moderate persistent asthma symptoms for a period of 6 month within the past year. At randomisation the asthma is considered stable and the intake of budesonide is <800 mcg/day A clinical history consistent with mild to severe house dust mite induced allergic rhinitis for at least one year. Positive Skin Prick Test (SPT) response (wheal diameter >3mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. Positive specific IgE (>IgE Class 2) against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. A documented history of reversible airway obstruction. |
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E.4 | Principal exclusion criteria |
FEV1 < 70% of predicted value with appropriate medication. A clinical history of perennial allergic asthma and/or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites) A clinical history of chronic sinusitis A clinical history of severe asthma within the last two years. Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (serous otitis media not an exclusion criterion). Treatment by immunotherapy with HDM allergen within the previous 5 years.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is deficned as reduction in ICS dosage from baseline to first year of treatment. |
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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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 trial is defined as the date the database is locked based on the clean file. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |