Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Recent respiratory tract infection (\<8 weeks prior to Screening)
• Recent acute exacerbation of IPF (\<8 weeks prior to Screening)
• Current smokers or ex-smokers with \<6 months' abstinence prior to Screening

Egyéb

• Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan
• Mean early morning cough scale score ≥5 and rest of the day cough scale score \<5 (after rounding) during the second week of the baseline assessment period (assessed at Visit 2)
• Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis

• Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
• FEV1/FVC ratio ≥0.65 at the screening visit
• Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit
• Arterial oxygen saturation on room air or oxygen ≥90% at Screening
• Life expectancy of at least 12 months
• Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening
• Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second week of the baseline assessment period