Condition category
Respiratory
Date applied
20/08/2012
Date assigned
09/10/2012
Last edited
12/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pulmonary fibrosis is a disease in which scars form in the lung tissues, leading to serious breathing problems such as perpetual shortness of breath. Previous studies have shown clinical improvement in patients treated with the drug co-trimoxazole. The aim of this study is to expand a previous small study to a larger study and confirm whether co-trimoxazole is effective at treating pulmonary fibrosis.

Who can participate?
Patients aged 40 to 86 with pulmonary fibrosis.

What does the study involve?
Participants are randomly allocated to be treated with either co-trimoxazole or an identical placebo (dummy drug) for 12 weeks. Participants are assessed with walking tests, lung function tests, questionnaires and blood tests.

What are the possible benefits and risks of participating?
The risks are minimal and the safety of cotrimoxazole is well established in transplant cases and other immune-suppressed patients, where it is used long-term. The study excludes those allergic to cotrimoxazole (septrin) and requires patients to take folic acid for bone marrow protection. The study is short (12 weeks) and placebo patients can receive active treatment after that so they are not denied active treatment for long.

Where is the study run from?
St Helier Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2012 to September 2016

Who is funding the study?
Peel Medical Trust Fund, Rotary Club and the Morriston-Davies Trust (UK).

Who is the main contact?
Dr Veronica Varney
veronica.varney@esth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Veronica Varney

ORCID ID

Contact details

St Helier Hospital
Wrythe lane
Carshalton
surrey
SM51AA
United Kingdom
+44 (0)20 8296 2401
veronica.varney@esth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06-09-2006-0208-296-2401

Study information

Scientific title

A double-blind, randomised, placebo-controlled study of co-trimoxazole in advanced pulmonary fibrosis

Acronym

Study hypothesis

Cotrimoxazole may have therapeutic benefit pulmonary fibrosis (both UIP/IPF and Fibrotic NSIP)

Ethics approval

South East Research Ethics Committee, 15/08/2007, ref: 07/MRE01/36

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced pulmonary fibrosis (UIP/IPF and fibrotic NSIP)

Intervention

The study will consist of two phases:
1. Double-blind randomised phase (3 months)
2. Open-label extension phase (to complete 12 months on treatment)

Intervention type

Drug

Phase

Not Applicable

Drug names

Co-trimoxazole

Primary outcome measures

Change from baseline to 3 months in forced vital capacity

Secondary outcome measures

Change from baseline to 3 months in:
1. Shuttle walking test
2. Symptom score on the MRC 5-Point Dyspnoea Scale.
3. Total lung capacity
4. Pulmonary gas exchange, as measured by DLCO and KCO
5. Cough, as measured by diary cards
6. SGRQ
7. Resting oxygen saturation on air
8. Chest radiograph
9. Changes in pulmonary cytokines relevant to this disease at entry & 3 months

A further efficacy endpoint will be a formal assessment of response to therapy (Favourable Response, Stable Response, Failure of Response) as defined in the ATS/ERS International Consensus statement (2000).

Overall trial start date

01/09/2012

Overall trial end date

01/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female
2. Aged 40 – 86 years
3. An established clinical history consistent with IIP according to the criteria for diagnosis outlined in the ATS/ERS consensus statement. (Bronchoscopic and/or biopsy data, although desirable, are not required for patient entry into the trial)
4. Clear cut HRCT evidence of UIP or fibrotic NSIP. An HRCT within 6 months of study enrolment is required. Lung function within 3 months of enrolement
5. Permitted concurrent therapies are:
5.1. Prednisolone 1 – 30 mg per day, established for at least 3 months at study entry
5.2. Short burst oxygen therapy for symptomatic benefit only
6. Stability of the disease process itself following the introduction of prednisolone is not required for study entry
7. Patients in whom oral steroids have been withdrawn due to lack of efficacy are eligible
8. Oxygen desaturation below 90% on a shuttle-walking test
9. MRC score of 3 or more

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. A secondary cause for pulmonary fibrosis
2. Subject currently smokes
3. A recognized coexisting respiratory disorder (e.g. significant COPD, asthma, sarcoid or lung carcinoma) that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures
4. A requirement for long-term oxygen therapy (LTOT) at entry as defined by the prescription of oxygen to be used for greater than or equal to 12 hours therapy per day
5. Overt and persistent right heart failure
6. Inability to perform the shuttle walking tests
7. Women who are pregnant, or who have the potential to become pregnant during the course of the study, or who are breast feeding
8. Co-trimoxazole allergy or prior known intolerance
9. Untreated vitamin B12 deficiency
10. Suspected or known glucose-6-phosphate dehydrogenase deficiency
11. Impaired renal function with an established creatinine greater than 175 ìmol/l
12. The following therapies will not be permitted on entry to the study:
12.1. Long-term oxygen therapy (LTOT)
12.2. Azathioprine
12.3 Cyclophosphamide
12.4. Methotrexate
12.5. D-penicillamine
12.6. Colchicine
12.7. Gamma-interferon
13. The following therapies will require caution or increased monitoring:
13.1. Digoxin
13.2 Warfarin
13.3. Phenytoin
13.4. Sulphonylureas
13.5. Procainamide hydrochloride

Recruitment start date

01/09/2012

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Helier Hospital
surrey
SM51AA
United Kingdom

Sponsor information

Organisation

St Helier Hospital (UK)

Sponsor details

Wrythe Lane
Carshalton
Surrey
SM5 1AA
United Kingdom
+44 (0)20 8296 2848
yvonne.reilly@esth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.epsom-sthelier.nhs.uk/

Funders

Funder type

Charity

Funder name

Peel Medical Trust Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Rotary Club Banstead, Surrey (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Morriston Davies Joint Fellowship (UK)

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

Publication citations

Additional files

Editorial Notes