Double Blind Randomised Placebo Controlled Trial of Oral Co-trimoxazole in Pulmonary Fibrosis
| ISRCTN | ISRCTN80334919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80334919 |
| Secondary identifying numbers | UK study number for local regional ethical committee (LREC) 64/99 |
- Submission date
- 25/08/2005
- Registration date
- 09/09/2005
- Last edited
- 05/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Veronica Varney
Scientific
Scientific
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| Phone | +44 (0)20 8296 2401 |
|---|---|
| vvarney@epsom-sthelier.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Double Blind Randomised Placebo Controlled Trial of Oral Co-trimoxazole in Pulmonary Fibrosis |
| Study acronym | Septrin and CFA |
| Study objectives | Oral Co-trimoxazole improves exercise capacity in patients with pulmonary fibrosis |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 Georges 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, LFTs, 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Co-trimoxazole |
| Primary outcome measure | 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 study start date | 21/02/2000 |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/02/2000 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Helier Hospital
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
United Kingdom
Sponsor information
The Peel Trust Fund (UK)
Charity
Charity
Sceptre Court
40 Tower Hill
Gloucester
GL1 3NN
United Kingdom
"ROR" |
https://ror.org/05ag50972 |
|---|
Funders
Funder type
Charity
Part funded by The Peel Trust Fund for funding of placebo and Co-trimoxazole drugs only
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
Editorial Notes
05/07/2018: Publication reference added.
