A double-blind randomised placebo controlled study of cotrimoxazole in the treatment of advanced pulmonary fibrosis - cotrimoazole in advanced fibrotic lung disease

INTERVENTION: Trade Name: Cotrimoxazole tablets BP 400/80 Pack size =28 tablets Product license (marketing authority) PL 17736/0079 marketing authorisation holder:‐ Essential Generics. 7 Egham buisness Village, Crabtree road, Egham, Surrey. TW208RB. UK Tel 01784477167 Product Name: Cotrimoxazole Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Product Name: cotrimoxazole Pharmaceutical Form: Tablet CONDITION: Advanced pulmonary fibrosis including common subtypes of usual interstitial pneumonitis and fibrotic non specific pneumonitis PRIMARY OUTCOME: Main Objective: To expand the original pilot study of 20 patients to full power (140 patients)in a double blind randomised placebo controlled study with the study method identical to the original pilot in every detail. The pilot showed highly significant improvement in all measured parameters and fulfilled the American & European criteria of a response to treatment in this disease and is now published in the Journal of pulmonary pharmacology & therapeutics; Primary outcome Improved shuttle walking distance and Forced vital capacity Primary end point(s): Based on ATS/ERS Consensus statment criteria; Change FVC by +10%; Improved shuttle walking distance; Reduced cough and symptoms scores such as MRC dyspnoea score Secondary Objective: Cough diary cards; Quality of life scores; reduced hospital admissions/ exacerbations; reduced requirement for oxygen INCLUSION CRITERIA: Male & female 40‐80 yrs . History and investigationssupport a diagnosis of pulmonary fibrosis. Ct scan but biopsy not essential. Patients maybe established on prednisolone (1‐30mg) or have ceased prednisolone due to lack of effect.Patients must show oxygen desaturation on exercise to below 90% on shuttle walking test and score MRC dyspnoea score 3 or above 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) yes F.1.3.1 Number of subjects for this age range