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Double Blind Randomised Placebo Controlled Trial of Oral Co-trimoxazole in Pulmonary Fibrosis

Double Blind Randomised Placebo Controlled Trial of Oral Co-trimoxazole in Pulmonary Fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80334919
Enrollment
20
Registered
2005-09-09
Start date
2000-02-21
Completion date
Unknown
Last updated
2018-07-30

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

Conditions

Idiopathic pulmonary fibrosis (UIP/NSIP/Mixed) Circulatory System Pulmonary fibrosis

Interventions

Investigations prior to selection and randomisation: All selected patients underwent baseline investigations before entry. This included: 1. Arterial gases at rest (on air) 2. Pulmonary function tests
using identical placebo tablets and labelling to ensure all treatment packs were identical. Drug Treatment: Co-trimoxazole or identical placebo (480 mg) tablets were supplied with dosage according to

Sponsors

The Peel Trust Fund (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female below 85 years old 2. Demonstrated breathlessness with oxygen desaturation below 90% on two baseline shuttle walking tests (SWT) 3. Physical examination, HRCT scan and pulmonary function test results compatible with IPF (with or without histological diagnosis) 4. New diagnosis of IPF without treatment or previous diagnosis on regular daily prednisolone 5. Symptoms of exertional dyspnoea affecting life quality 6. Normal glucose 6-phosphate dehydrogenase levels to avoid drug induced haemolysis. Normal vitamin B12 levels

Exclusion criteria

Exclusion criteria: 1. Recognised secondary causes of pulmonary fibrosis 2. Co-trimoxazole allergy or severe upper GI symptoms 3. Abnormal liver function tests or concurrent drug treatments that disturb liver function including azathioprine 4. Inability to perform the shuttle test due to musculoskeletal or cardiac causes

Design outcomes

Primary

MeasureTime frame
Exercise capacity (shuttle walking test) with area under the curve oxygen desaturation

Secondary

MeasureTime frame
1. Respiratory function tests (FVC, TLC, DLCO) 2. Arterial oxygen measurements 3. Quality of life data 4. Benefit of pulmonary rehabilitation Twenty patients were selected.

Countries

United Kingdom

Outcome results

None listed

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