Phase 3 Interstitial Lung Disease Trial, Recruiting NCT04965298 Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust Condition: Interstitial Lung Disease
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Phase 3 Interstitial Lung Disease Trial, Recruiting

NCT04965298
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are aged 40 years or older
  • You have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring condition, confirmed by a specialist team following current medical guidelines
  • You may already be taking approved anti-fibrotic (anti-scarring) medication, as long as you have been on a stable dose for at least 4 weeks before joining and plan to stay on the same dose for at least 4 weeks after joining
  • You are able to understand and agree to take part in the study (give informed consent)

For a smaller part of the study about cough monitoring, you may also need to:

  • Have an ongoing troublesome cough that has lasted more than 8 weeks before joining the study

Who may not be able to join:

  • You are unable to complete the study tests, including a breathing test called spirometry
  • You have taken certain medicines for acid reflux or stomach emptying (such as omeprazole, cisapride, domperidone, metoclopramide, erythromycin, or prucalopride) within the 2 weeks before joining
  • You have had a chest or respiratory infection in the 4 weeks before your initial assessment, involving two or more symptoms such as increased cough, more phlegm, or increased breathlessness, and needed antibiotic treatment
  • You have another significant lung or breathing condition (besides IPF) that is noticeably affecting your symptoms or health (confirm with trial site)
  • Your breathing test results show a specific pattern that suggests airflow obstruction (an FEV1/FVC ratio below 0.7) (confirm with trial site)
  • You have a serious medical, surgical, or mental health condition that your doctor feels could affect your safety or the study results — this includes significant liver problems, moderate-to-severe kidney disease, severe inflammation of the food pipe (oesophagus), a condition called Barrett's oesophagus, or any condition that means you need to take acid-reducing medication (proton pump inhibitors) permanently
  • You have a known allergy to proton pump inhibitor medicines or the ingredients in the dummy (placebo) treatment used in this trial
  • You are currently taking any of the following medications: atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, or fluvoxamine
  • You are a woman who is able to become pregnant or who is currently breastfeeding
  • You have taken part in another clinical trial involving a new drug or treatment within the past 4 weeks (or longer, depending on that drug) before joining this study
  • You are currently using long-term oxygen therapy at home
  • You have low magnesium levels in your blood (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Professor Andrew Wilson, Norfolk and Norwich University Hospitals NHS Foundation Trust

Phone: 01603 591224

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Registry
ClinicalTrials.gov
Start date
16 June 2021
Est. completion
28 February 2026

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Absolute change in percent predicted (%) forced vital capacity (FVC)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov