Treating pulmonary fibrosis with co-trimoxazole

• Research type

  Research Study

• Full title

  The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC)

• IRAS ID

  146057

• Contact name

  Andrew Wilson

• Contact email

  a.m.wilson@uea.ac.uk

• Sponsor organisation

  Norfolk and Norwich University Hospital

• Eudract number

  2014-004058-32

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Pulmonary fibrosis is a condition with limited treatment options. In a previous study we showed that people with pulmonary fibrosis who regularly took an antibiotic (called co-trimoxazole) were 5 times more likely to be alive after one year than those that didn’t. However, treatments for pulmonary fibrosis have now changed and we are trying to find out if co-trimoxazole is still as effective. We want to know whether co-trimoxazole, when given alongside current treatments, improves life expectancy and/or reduces the chances of being admitted to hospital for people with pulmonary fibrosis and, by measuring biomarkers (see below, how it may be working. We are aiming to recruit 330 participants from different regions throughout the UK. All patients must have some degree of breathlessness and reduced breathing tests and not have major health problems, problems with their liver or kidneys. After completing initial assessments and safety blood tests, participants will be randomised to receive either co-trimoxazole 960mg twice daily or a placebo tablet for between 1 year and 3.5 years depending on when they start the study. We will record the time until either a participant is admitted to hospital, has a lung transplant or dies. Questionnaires, breathing tests and blood for biomarkers (chemicals that allow us to understand about pulmonary fibrosis) will be completed or taken after 3 months, 6 months then every 6 months until the study ends. Patients will be invited to provide a blood sample for genetic testing. Fifty patients will be invited to have a bronchoscopy (lung camera test) to find out if co-trimoxazole has an effect on the numbers or amount of inflammatory cells, biomarkers and bacteria (using traditional and new techniques). It is hoped that this study will confirm whether co-trimoxazole has a benefit for patients and, if so, how it may be working.

  Lay Summary of Results:

  Out of 342 people who took part in the study (average age 71, 13% women), 83% completed it. On average, participants were followed for about a year. The number of health events was similar between those who received the antibiotic co-trimoxazole and those who received a placebo (dummy treatment). There was no meaningful difference in lung function, patient-reported outcomes, or other health events between the two groups.

  People in the co-trimoxazole group reported more side effects overall (696 vs 640 in the placebo group). Common side effects in the co-trimoxazole group included nausea (89 cases), diarrhea (52), vomiting (28), and rash (31). The placebo group also experienced similar side effects, though the numbers were slightly different.

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F33289822%252F%2FNBTI%2FmjO-AQ%2FAQ%2F25b9e0ba-bdb2-4564-99b1-2dbd7df31ad9%2F2%2FVrXBJvVvYg&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ca2032233b4294b6a3cd308ddd5c612c4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638901768891547434%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=9nDBa4WQAnslwzEyQUPbTJ39YHP6n%2B8AfPbrR7L9dqo%3D&reserved=0
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F33289822%252F%2FNBTI%2FmjO-AQ%2FAQ%2F25b9e0ba-bdb2-4564-99b1-2dbd7df31ad9%2F2%2FVrXBJvVvYg&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ca2032233b4294b6a3cd308ddd5c612c4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638901768891584891%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=A3kvRw%2FyirRig%2F0EGfC1XyZGrPgcvj7TLKABSnXUoD8%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F33289822%252F%2FNBTI%2FmjO-AQ%2FAQ%2F25b9e0ba-bdb2-4564-99b1-2dbd7df31ad9%2F2%2FVrXBJvVvYg&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Ca2032233b4294b6a3cd308ddd5c612c4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638901768891617756%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hSpXlG9ukqhTJUZbI2CqPMfnSK1xEcSq%2Bl%2F7UwXHFwQ%3D&reserved=0

  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: We arranged a dissemination event and forwarded copies of the lay summary as requested.
  If pending, date when feedback is expected:
  If no, explain why they haven't: We did not collect details of participants. The ethical approval dates back to 2015
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: Requests for access to trial data and stored samples were considered, and approved in writing where appropriate, after formal application to the TMG and TSC
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: Requests for access to trial data and stored samples were considered, and approved in writing where appropriate, after formal application to the TMG and TSC
  If no, explain why:
  Captcha: 03AFcWeA6mTZ1rYwqtfj2JoLhIlgHN0cEPUSssVdgfX5bdFEfpMxfg6dTqhDLCOgW-NXA81OdrQTpqJIyd68lIFz8XDhkZyQ7hMWZwEISibDkYZgdvSRqDvKSQ8_GqkglP40P4QuQn4-mlBrlpr-O9mrai8xRBzDor7qKlfKoQZuSxHLNJ4TbV8GqC_ONyysGbwMuy6t_jvUueX81BQqzZD9R91adrUbgZUiMyhyZb4F97jOL2-ErnJBquoDIC6fX6fZz8Jwfk9HbZXq04CH_9b-HpUt5JNkMj0QXkvh4z4J9LCvT6A1Ml0l7-GfAiTXl06vE7QBmRqc8uqcCwEDVvvxQnz824JIBUMsOWqy6Pu_ZtDAeTABYCfVSjdJyfvaIinhALPdCw_KUnBnMtZWzmCNZufoYen3FNbDeIFF_ShYiHA6e4C714rMl2a8O2ArgIBVy0NsCwR6REYUKO4WuwrcrhavjHI3xlyMBUgCsBVFSXoqDj5kdMI26BjNKtkmlcsaVSmzMpnolK3dNx3QiGo3LZC2vNusnfV7I8x5pHT_tmyNxCbZ85UnKvk6-b2Mjb5a42vWtpjsgtP8hXwrY1wb9alOZ59bdejKhWIiyq4eJTi0NoDGIp8w4Kd8dkK03B--Orsw2EDswg-xSle3k4PFtOFGh3qVTQ6qILbmeZ6uxi7OyIDI0eKoGZPwSEk4kg8mwXNDeGXo5MiNpMystC9ljqBPXMTwXwBMU62qKbr1qQKR6C2a2d1BTJsJvSZ_eIiB7weRgWZdLNb_on9Afu8_unzqImWOwoSwa0Nf7LQNe-1akoF8uoV9B5Eze165g2Zq6d2LSgVzM0jEYWP0mbj9SI6FzfZRI7uKgcqxH1fQcl7XtIlborUXGuTkRQMSyoEtduKgqiesMj3oV0Zy3b85NeejMeoXEtnvNvHIM3T-ODH4hyE5WFajUrIPSz9MO5dxbtPuXtJXIM
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/1800

• Date of REC Opinion

  24 Nov 2014

• REC opinion

  Further Information Favourable Opinion