Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

Endpoints

Primary

Adverse events

Timeframe: Through study completion, an average of 9 months

Secondary (14)

Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year)

Difference between pre-treatment and on-treatment annualized rate of FVC decline (% predicted/year)

Difference between pre-treatment and on-treatment annualized rate of DLCO decline (% predicted/year)

Change from baseline in K-BILD domain scores

Change from baseline in FVC (mL and % predicted)

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Change from baseline in DLCO (% predicted)

Incidence of serious adverse events

Permanent discontinuation of nerandomilast

Dose reduction of nerandomilast

Annualized incidence of acute exacerbation of interstitial lung disease

Annualized incidence of respiratory-cause hospitalization

Annualized all-cause mortality

Annualized incidence of lung transplantation

Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy

Arms and interventions

IPF or PPF

Patients who are diagnosed with IPF

Drugs: Nerandomilast

Sites

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