Tolerability testing

Our phase II studies test the treatment on a larger group of people who have interstitial lung disease or lung infection to see if it is well tolerated and safe and to see if there are early indicators that it might help the participants with these conditions.

If you are interested in any of these studies, please talk to your Respiratory Team.

Interstitial lung diseases

  • The CANAL Study: A phase II, double-blind, randomized, placebo-controlled, two-treatment, two-period crossover efficacy and safety study in Idiopathic Pulmonary Fibrosis with Nalbuphine ER tablets for the treatment of cough:
    • To investigate the efficacy and safety of Nalbuphine ER tablets in reducing chronic cough in patients diagnosed with IPF.  Now closed to recruitment following positive interim analysis results; read the published results.
  • The AIR Study / C21 in IPF: A phase 2, multi-centre, open-label, single-arm trial investigating the safety, efficacy and pharmacokinetics of C21 in subjects with Idiopathic Pulmonary Fibrosis:
    • The purpose of this study is to treat participants with C21 twice daily for a minimum of 3 months and up to 9 months, to see if it can slow down the scarring and improve breathing. Specifically, the study compares breathing ability before and after C21 treatment. Now closed to recruitment. Results have been favourable and the sponsors are continuing to develop this therapy. 
  • The CORAL Study: A randomized, double-blind, placebo-controlled, parallel, 4-Arm dose ranging study of the safety and efficacy of Nalbuphine  Extended-Release tablets for the treatment of cough in Idiopathic Pulmonary Fibrosis
    • To evaluate the effect of Nalbuphine ER on the mean 24-hour cough frequency (coughs per hour) using digital cough monitoring.
  •  

COVID-19

  • COVASE Study – Investigation of an approved nebulised human Dnase enzyme (Pulmozyme) to reduce hyperinflammation in hospitalised people with COVID-19:
    • The purpose of this trial is to provide nebulised Pulmozyme that is expected to reduce the inflammation and stop COVID-19 from getting worse. Nebulised Pulmozyme has been used to treat thousands of adults and children with cystic fibrosis safely since 1994.  The study is now closed and the results are in publication.  Awaiting information to see if this medication would be useful in ILD, especially in acute exacerbations.

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