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

Not Applicable

Completed

• Conditions: Idiopathic pulmonary fibrosis (UIP/NSIP/Mixed); Circulatory System; Pulmonary fibrosis

• Registration Number: ISRCTN80334919
• Lead Sponsor: The Peel Trust Fund (UK)

Brief Summary

2008 results in https://www.ncbi.nlm.nih.gov/pubmed/17500020

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-02-01
• Study Start: 2005-09-09
• Last Update Posted: 30 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity (shuttle walking test) with area under the curve oxygen desaturation

Secondary Outcome Measures

Name	Time	Method
1. Respiratory function tests (FVC, TLC, DLCO)<br>2. Arterial oxygen measurements<br>3. Quality of life data<br>4. Benefit of pulmonary rehabilitation<br>Twenty patients were selected.