Status:
RECRUITING
Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Norwich Clinical Trials Unit
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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....
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a progressive and usually fatal lung disease with a poor prognosis. IPF patients frequently have other medical conditions as well, with reflux disease being one ...
Eligibility Criteria
Inclusion Criteria:
- Male or female, aged greater than or equal to 40 years.
- A diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on local or regional multi-disciplinary consensus according to the latest international guidelines (50).
- 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).
- 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:
- Patients unable to comply with study assessments including the ability to complete reliable spirometry assessments.
- Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, prucalopride etc.) within 2 weeks prior to randomisation.
- 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).
- 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 traction bronchiectasis is permitted.
- Patients with an FEV1/FVC<0.7.
- 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 > 2 x upper limit of normal (ULN), Bilirubin > 1.5 x ULN (unless the patient has Gilbert's Syndrome) and chronic kidney disease (CKD) greater than stage 3 , erosive oesophagitis, Barrett's oesophagus or any condition requiring lifelong proton pump inhibitor use.
- Known allergy to proton pump inhibitors or the contents of placebo.
- Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5).
- Females who are of childbearing potential or lactating. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- 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.
- Receiving long-term oxygen therapy.
- Patients with hypomagnesemia (defined as magnesium ≤0.6 mmol/L).
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT04965298
Start Date
June 16 2021
End Date
February 28 2026
Last Update
December 22 2025
Active Locations (57)
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1
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
2
NHS Grampian
Aberdeen, United Kingdom, AB15 6RE
3
Northern Health and Social Care Trust
Antrim, United Kingdom, BT41 2RL
4
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom, RG24 9NA