A double-blind, randomised, placebo-controlled study of co-trimoxazole in advanced pulmonary fibrosis

St Helier Hospital (UK)0 个研究点目标入组 140 人开始时间: 2012年10月9日最近更新: 2021年11月15日

试验速览

•1. Male or female
•2. Aged 40 ? 86 years
•3. An established clinical history consistent with IIP according to the criteria for diagnosis outlined in the ATS/ERS consensus statement. (Bronchoscopic and/or biopsy data, although desirable, are not required for patient entry into the trial)
•4. Clear cut HRCT evidence of UIP or fibrotic NSIP. An HRCT within 6 months of study enrolment is required. Lung function within 3 months of enrolement
•5. Permitted concurrent therapies are:
•5.1. Prednisolone 1 ? 30 mg per day, established for at least 3 months at study entry
•5.2. Short burst oxygen therapy for symptomatic benefit only
•6. Stability of the disease process itself following the introduction of prednisolone is not required for study entry
•7. Patients in whom oral steroids have been withdrawn due to lack of efficacy are eligible
•8. Oxygen desaturation below 90% on a shuttle-walking test
•9. MRC score of 3 or more

•1. A secondary cause for pulmonary fibrosis
•2. Subject currently smokes
•3. A recognized coexisting respiratory disorder (e.g. significant COPD, asthma, sarcoid or lung carcinoma) that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures
•4. A requirement for long-term oxygen therapy (LTOT) at entry as defined by the prescription of oxygen to be used for greater than or equal to 12 hours therapy per day
•5. Overt and persistent right heart failure
•6. Inability to perform the shuttle walking tests
•7. Women who are pregnant, or who have the potential to become pregnant during the course of the study, or who are breast feeding
•8. Co-trimoxazole allergy or prior known intolerance
•9. Untreated vitamin B12 deficiency
•10. Suspected or known glucose-6-phosphate dehydrogenase deficiency
•11. Impaired renal function with an established creatinine greater than 175 ìmol/l
•12. The following therapies will not be permitted on entry to the study:
•12.1. Long-term oxygen therapy (LTOT)
•12.2. Azathioprine
•12.3 Cyclophosphamide
•12.4. Methotrexate
•12.5. D-penicillamine
•12.6. Colchicine
•12.7. Gamma-interferon
•13. The following therapies will require caution or increased monitoring:
•13.1. Digoxin
•13.2 Warfarin
•13.3. Phenytoin
•13.4. Sulphonylureas
•13.5. Procainamide hydrochloride

发起方

St Helier Hospital (UK)