Fibrotic hypersensitivity pneumonitis Respiratory
Conditions
Interventions
Participants will be randomised into the trial by a delegated member of the site team using an online randomisation service. Trial participants will be randomised on a 1:1 ratio to receive either 26 w
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. ILD multi-disciplinary diagnosis of FHP within the last 6 months 3. % predicted FVC =40% at baseline (as per GLI equation) 4. % predicted DLCO =25% at baseline 5. FEV1/FVC ratio =0.7 at baseline 6. >10% fibrosis on CT taken as standard of care for the MDT diagnosis 7. Able to provide informed consent 8. People of child-bearing potential must be willing to: 8.1. Take a pregnancy test at baseline, before randomisation 8.2. Use of a highly effective method of contraception for the duration of the trial (35 weeks) 8.3. Inform the research clinical team if pregnancy occurs during trial participation
Exclusion criteria
Exclusion criteria: 1. Previous or current therapy with prednisolone or other immunosuppressive agent for FHP 2. Active infection (use of antibiotics must be completed 2 weeks prior to the baseline visit. Prophylactic antibiotics are allowed) 3. Emphysema>fibrosis on CT scan 4. BMI>44 kg/m2 5. Currently enrolled in another investigational drug trial 6. Non-respiratory conditions requiring use of immunosuppressive therapy (including prednisolone) 7. Any condition that might be significantly exacerbated by the administration of prednisolone, including but not limited to: Cushing’s and Conn’s Syndromes, Addison’s disease, poorly controlled/difficult to control diabetes 8. Patients with underlying liver cirrhosis (Child Pugh, B, or C hepatic impairment). 9. Stage 4/5 chronic kidney disease (eGFR <30 ml/min/1.73 m2) 10. Patients with unstable cardiac disease or a significant disease or condition other than the ILD under trial, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with trial procedures, or cause concern regarding the patient’s ability to participate in the trial 11. Use of potent inducers of prednisolone including phenytoin, rifabutin, carbamazepine, ketoconazole, rifamycins. Please refer to the Summary of Product Characteristics 12. Patients with ocular herpes simplex 13. Known allergy to prednisolone or its excipients including lactose anhydrous or capsule ingredients hydroxypropylmethylcellulose, water, dye – copper complex of chlorophyllins E141ii 14. Pregnant, breastfeeding, or planning to conceive in the next 35 weeks
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute FVC, measured in millilitres (ml) will be recorded using the pulmonary function test (PFT) at 12 weeks post-randomisation and used to calculate change in absolute FVC between baseline and 12 weeks post-randomisation 2. Percentage change in FVC will be calculated (using the absolute FVC values collected at baseline, 12 and 26 weeks post-randomisation) between (i) baseline and 12 weeks and (ii) baseline and 26 weeks post-randomisation 3. Absolute change in percentage predicted FVC will be calculated between (i) baseline and 12 weeks and (ii) baseline and 26 weeks post-randomisation, using percentage predicted FVC calculated centrally by ExeCTU using Global Lung Initiative (GLI) reference equation 4. Absolute DLco, measured in mmol min-1 kPa-1 , will be recorded using the European Respiratory Society (ERS) guidelines, at baseline and 26 weeks post-randomisation and used to calculate change in absolute DLCO between baseline and 26 weeks post-randomisation 5. Percentage change in DLco will be calculated (using the absolute DLco values collected at baseline and 26 weeks post-randomisation) between baseline and 26 weeks post-randomisation 6. Absolute change in percentage predicted DLco will be calculated between baseline and 26 weeks post-randomisation. 7. Initiation of antifibrotic therapy given by 26 weeks post-randomisation as reported on additional therapies eCRF 8. Additional immunosuppressant therapy given by 26 weeks post-randomisation as reported on additional therapies eCRF 9. Quality of life will be measured at baseline, 12 and 26 weeks post-randomisation. Changes in quality of life from (i) baseline to week 12 and (ii) baseline to week 26 will be measured using patient-reported outcome measures (PROMs): 9.1. L-PF questionnaire (dyspnoea, cough and fatigue domain scores of principal interest) 9.2. PGI-S scale 9.3. The cough VAS 9.4. EQ-5D-5L – Visual Analogue Scale 10. Safety data will be collected in accordance with MedDRA and defined as the n | — |
Primary
| Measure | Time frame |
|---|---|
| Absolute FVC, measured in millilitres (ml), will be recorded using the pulmonary function test (PFT), at 26 weeks post-randomisation. The primary outcome is the change in absolute FVC between baseline and 26 weeks post-randomisation. | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed