Condition category
Circulatory System
Date applied
25/08/2005
Date assigned
09/09/2005
Last edited
14/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Veronica Varney

ORCID ID

Contact details

St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 2401
vvarney@epsom-sthelier.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UK study number for local regional ethical committee (LREC) 64/99

Study information

Scientific title

Acronym

Septrin and CFA

Study hypothesis

Oral Co-trimoxazole improves exercise capacity in patients with pulmonary fibrosis

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Idiopathic pulmonary fibrosis (UIP/NSIP/Mixed)

Intervention

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 (laboratory measurement of TLC, DLCO)
3. St George’s Hospital respiratory questionnaire (SGHRQ), and MRC 5 Point Dyspnoea Score
4. Two shuttle-walking tests (2 weeks apart) demonstrating oxygen desaturation below 90% (either during or upon cessation of exercise)
5. An echocardiogram and ECG
6. Routine bloods tests including serum samples for cytokine measurements
7. Sputum samples for pneumocystis silver stain at request of Ethics Committee

Randomisation:
Patients were randomly allocated to active or placebo treatments by our clinical trials pharmacist, using computer generated random numbers. This assigned patients to study treatment groups, with a patient number. The study was conducted double blind. To preserve the double blind status of the trial, medication was issued by the pharmacist; 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 body-weight. Patients up to 70 kg received 960 mg bd, those above 70 kg, took 1440 mg (3 x 480 mg) bd. Folic acid 5 mg was given 3 times a week (minimum dose) to protect the bone marrow. Ranitidine 150 mg bd was supplied but optional for any indigestion. Patients on oral daily prednisolone had no adjustments to their prednisolone dose throughout the double blind study, except that permitted during a viral illness.

Assessment during Study:
On entry to the study all patients made visits for the following assessments every 2 weeks:
1. Body-weight
2. Resting respiratory rate and chest auscultation
3. FVC
4. Oxygen saturations at rest and during shuttle walking test and recovery recorded by Pulsox 3i wrist watch Minolta range
5. MRC-5 Point Dyspnoea Score
6. Compliance with treatment/side effects/study withdrawal and deaths were assessed and recorded
7. Blood tests (FBC, U & E, LFT’s, ESR and CRP)
At 3 months all patients had arterial gases, full pulmonary function tests, serum cytokines and SGHRQ, repeated. Six weeks of pulmonary rehabilitation (rehab) was then commenced. Two weeks post rehabilitation final assessments were made before decoding. These assessments were identical to the regular 2 week assessments during the study.

Intervention type

Drug

Phase

Not Specified

Drug names

Co-trimoxazole

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

21/02/2000

Overall trial end date

01/02/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

21/02/2000

Recruitment end date

01/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Helier Hospital
Carshalton
SM5 1AA
United Kingdom

Sponsor information

Organisation

The Peel Trust Fund (UK)

Sponsor details

Sceptre Court
40 Tower Hill
London
EC3N 4DX
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Part funded by The Peel Trust Fund for funding of placebo and Co-trimoxazole drugs only

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Abstract presentation to Thorax, ATS and ERS. Submitted to JAMA for publication.

Publication citations

Additional files

Editorial Notes