Treating people with idiopathic pulmonary fibrosis with the addition of lansoprazole (TIPAL)

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 298

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

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 randomisation
3. 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 permitted
5. Patients with FEV1/FVC< 0.7
6. 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 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 < = 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 randomisation
3. 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 permitted
5. Patients with FEV1/FVC< 0.7
6. 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 conditi

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predicted (%) forced vital capacity (FVC) at 12 months post-randomisation

Secondary Outcome Measures

Name	Time	Method

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