E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 determine whether patients with severe therapy resistant asthma respond to treatment with the biological disease-modifying anti-rheumatic drug (DMARD) Adalimumab (Humira) |
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E.2.2 | Secondary objectives of the trial |
Monitor safety of severe asthma patient being treated with the biological disease-modifying anti-rheumatic drug (DMARD) |
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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 patient, over the age of 18 and under 65 years of age, at the date of consent 2. Diagnosis of Stage 4 Asthma, in accordance with the GINA guidelines 3. The patient has a documented diagnosis of asthma defined with a 12% reversibility of lung function by spirometry in the past 12 months 4. The patient has a screening FEV1 >=60 - 80% predicted normal value 5. Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder inhaler (DPI) >=500 ug/day or equivalent ex-valve dose during the 12 weeks prior to the screening visit 6.The patient has had at least one asthma exacerbation episode in the last 12 months. 7. The patient is capable of providing consent 8. The patient is willing to perform self-injection of the trial medication 9. The patient is fluent in and understands English
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E.4 | Principal exclusion criteria |
1. History of allergy or hypersensitivity to adalmumab; 2. Lifetime history of smoking >10 pack years or current smoker 3. Active tuberculosis or other severe infection such as sepsis, opportunistic infections 4. Life-threatening diseases, including: cancer; 5. History or suspicion of alcohol or drug abuse; 6. Pregnant or breast-feeding female; 7. Female patient of childbearing potential without adequate contraception; 8. The patient is currently being treated for infection with antibacterial, antiviral or antifungal agents. 9. Participation in an investigational drug trial in the 12 weeks prior to selection or current inclusion in any other trial or research project; 10. The patient has a history of endotracheal intubation within the last 6 months. 11. Patients who, in the opinion of the treating physician, will be inappropriate for inclusion into this survey or will not comply with requirements of the study. 12. An active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease) 13. The patient is receiving anti-coagulants (e.g. warfarin, thrombolytic enzymes or ticlopidine). 14. Presence or a history of a neurological condition such as Multiple Sclerosis 15. The patient has moderate to severe heart failure. 16. The patient has a history of or active SLE (Systemic lupus erythematosus) 17. The patient has a history of poor asthma medicine compliance.
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E.5 End points |
E.5.1 | Primary end point(s) |
A reduction in tissue eosinophils and CD4 lymphocytes by >50% |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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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40 day post last patient / last visit (follow-up telephone contact) |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |