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Sponsored by: |
Imperial College London |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00278083 |
This trial is a randomised, single-center, placebo-controlled, double blind, parallel group study in patients with asthma symptomatic on inhaled steroids.
This trial will examine the efficacy and safety of 5 mg/kg doses of infliximab in patients with inhaled corticosteroid-dependent asthma. The primary objective of this study is to obtain pharmacological evidence for a role of the pro-inflammatory cytokine TNF-alpha in patients with asthma symptomatic on inhaled steroids and to evaluate the safety and tolerability of repeated intravenous administration of infliximab.
Condition | Intervention | Phase |
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Asthma |
Drug: Study drug administration Procedure: Tuberculin intradermal skin test Procedure: Lung function test for FEV1 Procedure: Asthma symptom scores diary Procedure: Quality of life diary Procedure: Breath nitric oxide Procedure: Breath condensate Procedure: Sputum induction Procedure: Blood sampling Procedure: Urinalysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double Blind, Placebo-Controlled, Parallel Group Pilot Study to Determine the Effect of REMICADE on Safety, Efficacy and Biomarkers of Inflammation in Patients With Asthma Receiving Inhaled Corticosteroids |
Estimated Enrollment: | 40 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | April 2004 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
United Kingdom | |
NHLI Clinical Studies Unit | |
London, United Kingdom, SW3 6HP |
Principal Investigator: | Trevor T Hansel, FRCPath PhD | Imperial College London |
Study ID Numbers: | C0168T42 |
Study First Received: | January 17, 2006 |
Last Updated: | January 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00278083 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
Pharmacology Asthma TNF-alpha |
Vasodilator Agents Neurotransmitter Agents Antioxidants Bronchial Diseases Infliximab Anti-Asthmatic Agents Asthma Cardiovascular Agents Inflammation |
Nitric Oxide Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Vasodilator Agents Antioxidants Bronchial Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors |
Immune System Diseases Asthma Anti-Asthmatic Agents Cardiovascular Agents Protective Agents Pharmacologic Actions Nitric Oxide Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |