Adalimumab (Humira) as add-on therapy in the treatment of patients with severe persistent therapy resistant asthma

• Conditions: Severe Asthma

• Registration Number: EUCTR2005-005544-79-IE
• Lead Sponsor: The Clinical Research Centre, RCSI Education and Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified