A double-blind randomised placebo controlled study of cotrimoxazole in the treatment of advanced pulmonary fibrosis - cotrimoazole in advanced fibrotic lung disease
- Conditions
- Advanced pulmonary fibrosis including common subtypes of usual interstitial pneumonitis and fibrotic non specific pneumonitis
- Registration Number
- EUCTR2006-004927-12-GB
- Lead Sponsor
- St Helier Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
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
Secondary causes of lung fibrosis, orsignificant COPD,Asthma, sarciod that could invalidate the study outcome measures. Those on lontterm oxygen, Heart disease and those unable to perform the shuttle walking test. Pregnant women, cotrimoxazole allergy, untreated B12 & folate deficiency Renal failure with creatinine above 180. Known G-6-PD deficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>Primary outcome Improved shuttle walking distance and Forced vital capacity;Secondary Objective: Cough diary cards<br>Quality of life scores<br>reduced hospital admissions/ exacerbations<br>reduced requirement for oxygen;Primary end point(s): Based on ATS/ERS Consensus statment criteria<br>Change FVC by +10%<br>Improved shuttle walking distance<br>Reduced cough and symptoms scores such as MRC dyspnoea score
- Secondary Outcome Measures
Name Time Method