E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects suffering from house dust mite allergy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057631 |
E.1.2 | Term | House dust allergy |
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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 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 |
The secondary objectives of the trial are 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 rescue medication, number of asthma exacerbations, Quality of Life, lung function FEV1 and PEF and new sensitivities as measured by SPT The safety evaluations are based on Adverse events, 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 |
1. Male or female aged 14 years or above 2. Written informed consent obtained before entering the trial. For subjects aged 14-17 years written informed consent should also be available from parent s /guardian. 3. A clinical history of house dust mite induced mild to moderate persistent asthma1 of at least one year prior to trial entry 4. Use of an appropriate amount of inhaled corticosteroid in accordance with the GINA Guidelines2 for the control of the mild to moderate persistent asthma symptoms for a period of 6 months within the past year. 5. At randomisation the asthma is considered stable and the intake of budesonide is 800 mcg/day 6. A clinical history consistent with mild to severe3 house dust mite induced allergic rhinitis for at least one year. 7. Positive Skin Prick Test SPT response wheal diameter 3 mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae 1 Mild to moderate asthma corresponds to Step 2 and 3 in GINA Guidelines 2 See footnote 1 3 The classification of the mild to severe rhinitis symptoms correspond to the mild-severe classification described in the ARIA Guidelines ALK-Abell A/S Confidential 24 April 2006 Group Clinical Development Version 1 Clinical Trial Protocol MT-02 Final Page 24 of 72 8. Positive specific IgE IgE Class 2 against Dermatophagoides pteronyssinus and/or Dermatophagoides farinae 9. A documented history of reversible airway obstruction as judged by an improvement in absolute FEV1 12 or at least 200 ml after administration of short acting beta-2- agonist or an improvement in PEF 15 15-20 minutes after inhalation of a short acting beta-2- agonist or a diurnal variability in PEF 20 when treated with a bronchodilator 10 if not treated or a decrease in PEF 15 after 6 minutes of sustained running or exercise 10. If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate4 contraceptive methods for the duration of the trial |
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E.4 | Principal exclusion criteria |
1. FEV1 70 of predicted value with appropriate medication 2. 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 3. A clinical history of chronic sinusitis 4. A clinical history of severe asthma5 within the last two years 5. Current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process serous otitis media is not an exclusion criterion 6. Physical examination with clinically relevant findings 7. Use of an investigational drug within 30 days prior to screening 8. Treatment by immunotherapy with HDM allergen within the previous 5 years 9. History of anaphylactic shock 10. History of angioedema |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is defined 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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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) | 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.8.5 | 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
| |
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 | 4 |
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 |