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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Andrew
Wilson
+44 (0)1603 591257
a.m.wilson@uea.ac.uk
Mr
Matthew
Hammond
+44 (0)1603591224
tipal@uea.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Idiopathic pulmonary fibrosis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Idiopathic pulmonary fibrosis (IPF) is a progressive scarring lung condition causing coughing and breathlessness. IPF patients often have reflux disease meaning stomach acid may be breathed into the lungs, potentially damaging them. Medicines that stop stomach acid production, including proton pump inhibitors (PPIs), can be used to reduce reflux symptoms including heartburn. Some researchers suggest PPIs also reduce IPF progression.
This research aims to see if IPF progresses slower if treated with PPIs. Based on the results, the researchers will be able to recommend whether or not IPF patients should take PPIs.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39909521/ (added 07/02/2025)
You can take part if:
Current inclusion criteria as of 22/08/2023:
1. Male or female, aged greater than or equal to 40 years
2. A diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on local or regional multi-disciplinary consensus according to the latest international guidelines
3. Patients may be receiving licensed anti-fibrotic medication (for at least 4 weeks prior to randomisation with no planned amendments for at least 4 weeks post-randomisation)
4. Able to provide informed consent
Additional inclusion criteria for cough count sub-study:
1. Pre-existing diagnosis of persistent cough (defined as troublesome for more than 8 weeks prior
You may not be able to take part if:
Current exclusion criteria as of 22/08/2023:1. Patients unable to complete reliable FVC measurements (i.e. the difference between the two largest values is NOT < = 0.150 L)2. Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, pruclopride etc) within 2 weeks prior to randomisation3. Patients with a self-reported significant respiratory tract infection, including COVID-19, within 4 weeks of screening.4. Significant co-existing respiratory disease (defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the PI). The presence of bronchiectasis is permitted5. Patients with FEV1/FVC< 0.76. Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcomes including liver failure (e.g. serum transaminase > 2x upper limit of normal (ULN), bilirubin > 1.5x ULN (unless the patient has Gilbert's syndrome) and chronic kidney disease (CKD) no greater than stage 3 (stable for at least 3 months prior to enrolment), erosive oesophagitis, Barrett's oesophagus or any other condition requiring lifelong proton pump inhibitor use.7. Known allergy to proton pump inhibitors or the contents of placebo8. Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5 of protocol)9. Females who are of childbearing potential or lactating. Non-childbearing potential is defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhoea or 6 months of spontaneous amenorrhoea with serum FSH> 40mlU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment10. Receipt of another investigational drug or biological agent associated with another clinical trial within the 4 weeks prior to TIPAL study enrolment or 5 times the drug half-life, whichever is the longer11. Receiving long-term oxygen therapy12. Patients with hypomagesmesmia (defined as magnesium < = 0.6mmol/L)
Previous exclusion criteria:1. Patients unable to complete reliable FVC measurements (i.e. the difference between the two largest values is NOT < = 0.150 L)2. Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, pruclopride etc) within 2 weeks prior to randomisation3. Patients with a self-reported respiratory tract infection within 4 weeks of screening (defined as two or more of: increased cough, sputum or breathlessness and requiring antimicrobial therapy)4. Significant co-existing respiratory disease (defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the PI). The presence of bronchiectasis is permitted5. Patients with FEV1/FVC< 0.76. Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcomes including liver failure (e.g. serum transaminase > 2x upper limit of normal (ULN), bilirubin > 1.5x ULN (unless the patient has Gilbert's syndrome) and chronic kidney disease (CKD) no greater than stage 3 (stable for at least 3 months prior to enrolment), erosive oesophagitis, Barrett's oesophagus or any other condition requiring lifelong proton pump inhibitor use.7. Known allergy to proton pump inhibitors or the contents of placebo8. Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5 of protocol)9. Females who are of childbearing potential or lactating. Non-childbearing potential is defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhoea or 6 months of spontaneous amenorrhoea with serum FSH> 40mlU/ml or females who have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to enrolment10. Receipt of another investigational drug or biological agent associated with another clinical trial within the 4 weeks prior to TIPAL study enrolment or 5 times the drug half-life, whichever is the longer11. Receiving long-term oxygen therapy12. Patients with hypomagesmesmia (defined as magnesium < = 0.6mmol/L)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Andrew
Wilson
+44 (0)1603 591257
a.m.wilson@uea.ac.uk
Mr
Matthew
Hammond
+44 (0)1603591224
tipal@uea.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127479; National Institute for Health Research (NIHR) (UK).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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