E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to severe persistent asthma. |
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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 and compare the expression of key severe asthma targets at baseline such as IL-13, IKK2, p38 and CLCA1 in mild to moderate asthmatic vs. severe asthmatic subjects. • To evaluate and compare changes in the expression (from baseline) of key severe asthma targets in response to a two week course of corticosteroids (prednisolone) in mild to moderate asthmatic vs. severe asthmatic subjects. • To evaluate and compare airway pathology (e.g. inflammatory cells, airway thickness) at baseline, in relation to asthma severity. • To evaluate and compare changes in airway pathology (from baseline) following a two week course of corticosteroids (prednisolone) in mild to moderate asthmatics vs. severe asthmatics.
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E.2.2 | Secondary objectives of the trial |
• To evaluate and compare the expression of key biomarkers (at baseline and change from baseline following a two week course of corticosteroids) in mild to moderate asthmatic vs. severe asthmatic subjects. • To identify airway and systemic biomarkers associated with target expression and clinical measurements at baseline; as well as changes in biomarker expression that are associated with changes in target expression and changes in clinical measurements following the two week course of corticosteroids. |
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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 subject aged between 18-65 years inclusive at screening. 2. Have a history of mild to severe persistent asthma that must be documented for a minimum of 6 months prior to entry to the study, with exclusion of other significant pulmonary diseases. 3. A female subject of childbearing potential must be using effective contraceptive measures, as defined in POL/GMO/003: 4. Body mass index within the range 19-31 kg.m-2 5. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. |
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E.4 | Principal exclusion criteria |
1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study. 2. The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation. 3. Subject is female who is pregnant or lactating. 4. Currently or planning to take during the study regular medication (including over-the-counter) except for medication allowed in inclusion criteria. 5. Having participated within 30 days or 5 half-lives, whichever is longer of the first dose in a study using new molecular entity, or the first dose in any other study investigating drugs or having participated within one month of the first dose in a study with invasive procedures. 6. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments. 7. History of abnormal bruising or bleeding. 8. Female subjects who are unwilling or unable to use an appropriate method of contraception 9. Concomitant medications that may interfere with study procedures or evaluations. Examples include: Anticoagulants except low dose of Aspirin (80 mg per day) (for bronchoscopy) Beta blockers except for low dose Atenolol (25 mg/day) or Metoprolol (50 mg/day) (for bronchoscopy)
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E.5 End points |
E.5.1 | Primary end point(s) |
This study will assess multiple parameters in asthmatic patients at baseline and following a 2 week course of high dose corticosteroid (prednisolone therapy). These fall in to four main categories:
1. Those characterising airway pathology - histopathology; sputum ;BAL/bronchial wash; bronchial brushings
2. Those delineating target expression - protein expression; mRNA expression; specific pharmacology or target expression in blood; inflammatory markers in blood; proteomic analysis
3. Biomarkers - of disease severity; associated with target expression; of corticosteroid response
4. Clinical measurements - associated with disease severity; of corticosteroid response
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |