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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004927-12-GB

Enrollment

140

Registered

2010-01-13

Start date

2009-11-20

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced pulmonary fibrosis including common subtypes of usual interstitial pneumonitis and fibrotic non specific pneumonitis

Interventions

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, Cra

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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;Secondary Objective: Cough diary cards Quality of life scores reduced hospital admissions/ exacerbations reduced requirement for oxygen;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	—

Measure

Time frame

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;Secondary Objective: Cough diary cards Quality of life scores reduced hospital admissions/ exacerbations reduced requirement for oxygen;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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026