Idiopathic pulmonary fibrosis Respiratory Interstitial pulmonary diseases with fibrosis
Conditions
Interventions
This project is a clinical trial of an investigational medicinal product (drug). The drug (lansoprazole) is well established and approved for use for another medical condition. The drug will be assess
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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 to study enrolment) Previous inclusion criteria: 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 (Am J Respir Crit Care Med. 2018;198:e44-e68) 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 to study enrolment)
Exclusion criteria
Exclusion criteria: 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 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 placebo 8. 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 enrolment 10. 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 longer 11. Receiving long-term oxygen therapy 12. Patients with hypomagesmesmia (defined as magnesium 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 conditi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predicted (%) forced vital capacity (FVC) at 12 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cough frequency measured using a VitaloJAK cough monitor over a 24-h period at baseline and 3 months post-randomisation 2. Cough score measured using a 100-mm visual analogue scale (VAS) at baseline 3, 6, 9 and 12 months post-randomisation 3. Cough-related quality of life measured by the Leicester Cough Questionnaire at baseline, 3, 6, 9 and 12 months post-randomisation 4. Breathlessness measured by the Medical Research Council (MRC) Dyspnoea Scale at baseline, 3, 6, 9 and 12 months post-randomisation 5. Disease specific quality of life measured using the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire at baseline, 3, 6, 9 and 12 months post-randomisation 6. Health related quality of life measured using the EQ-5D-5L questionnaire at baseline, 3, 6, 9 and 12 months post-randomisation (quality-adjusted life-years will be estimated) 7. Adverse events with particular relevance to respiratory tract infection including pneumonia, Clostridium difficile infection and hypomagnesaemia measured at 3, 6, 9 and 12 months post-randomisation 8. Total lung diffusing capacity of carbon monoxide (DLCO) measured at baseline, 3, 6 and 12 months post-randomisation 9. Sleep quality measured by the short Pittsburgh Sleep Quality Index at baseline, 3 and 12 months post-randomisation 10. Reflux characteristics measured by the DeMeester score at baseline, 3 and 12 months post-randomisation 11. Participant acceptability of trial treatment measured by a non-validated study-specific questionnaire at 12 months post-randomisation 12. Risk of sleep apnoea measured by the STOP-bang questionnaire at 12 months post-randomisation 13. Progression free survival (with progression defined as all-cause death, lung transplant, a 10% reduction in FVC % predicted from baseline, or 15% reduction in DLCO % predicted from baseline) at 12 months post-randomisation 14. Hospital-free survival defined as death (all causes) or first non-elective (all-cause) hospital admission at 12 months post-random | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactIzobel Clegg
Outcome results
None listed