TNF-alpha Directed Therapy in Asthma

Launched by IMPERIAL COLLEGE LONDON · Jan 17, 2006

Keywords

ClinConnect Summary

Study Overview This trial is a randomised, single-center, placebo-controlled, double blind, parallel group study in patients with asthma symptomatic on inhaled steroids.

Patient Population Patients eligible for this study will have a diagnosis of moderate asthma defined by the American Thoracic Society criteria for \> 1 year. These patients should be taking inhaled steroids at doses equivalent to \= 400µg and \= 2000µg per day beclomethasone diproprionate but not oral steroid medication. Patients taking additional oral steroids are required to stop oral medication at least one month pr...

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have a diagnosis of moderate asthma as defined by the American Thoracic Society criteria (NIH, 1997) for \> 1 year.
• • 2. Men and women, \>/= 18 to \</= 60 years of age and within 60-140% of desirable height and weight range established by the 1983 Metropolitan Life Insurance Company standards.
• • 3. Non-smoker for at least 1 year and less than a 10 pack year history of smoking.
• • 4. Screening values for haematology, biochemistry and urinalysis should be within clinically acceptable limits for this patient group.
• • 5. Chest radiograph at screening must show no evidence of malignancy, infection, or fibrosis. The chest radiographs should also show no apical scarring, cavitary lesions, or calcified granulomas, as evidence of past tuberculosis infections.
• • 6. Serological assays for hepatitis B and C must be negative for active infection.
• Exclusion Criteria:
• • 1. Are pregnant, nursing, or planning a pregnancy within 12 months of enrolment.
• • 2. Diagnosis of chronic obstructive pulmonary disease, cystic fibrosis or other significant respiratory disorder (excluding asthma).
• • 3. Exacerbation of asthma symptoms requiring hospitalisation within the previous 12 weeks.
• • 4. History of clinically significant seasonal allergies will require that the patient is studied outside the allergy season.
• • 5. Have been previously treated with infliximab or any other therapeutic agent targeted at reducing TNF.
• • 6. Have been treated with any anti-CD-4 antibody.
• • 7. Have been treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater.
• • 8. Have previously used cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.
• • 9. Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.
• • 11. Have had a serious infection during the previous 2 months. 12. Have a chronic or recurrent infectious disease 13. Have a history of opportunistic infections 14. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
• • 15. Have a history of lymphoproliferative disease, including lymphoma 16. Currently have any known malignancy or have a history of malignancy within the previous 5 years.
• • 17. Have had substance abuse (drug or alcohol) problem within the previous 10 years.
• • 18. Use of restricted respiratory medication prior to screening within the following time periods: 1) oral or systemic steroids, 1 month; 2) immunosuppressant therapy, 3 months.
• • 19. Have a history of chronic cough, haemoptysis, weight loss, or pyrexia considered suggestive of possible current tuberculosis infection.
• • 20. Patients with current active tuberculosis (TB) or atypical mycobacterial infection or a previous history of these infections.
• • 21. Be considered at high risk for tuberculosis according to US Centers for Disease Control and Prevention (CDC) criteria, 22. A tuberculin (purified protein derivative, PPD) intradermal skin test \> 10mm induration.
• • 23. Have demyelinating disease (multiple sclerosis), autoimmune conditions such as systemic lupus.