The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines.
Chronic cough for ≥8 weeks prior to Screening.
PGI-Severity Score ≥ 2 at Screening.
Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.
Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.
Parallel
NAL ER
DrugOral tablets
Placebo
DrugOral tablets
Relative Change from Baseline in 24-hour Cough Frequency at Week 26
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26
Relative Change from Baseline in 24-hour Cough Frequency at Week 6
Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26
Click on the lead sponsor to view all of their trials.
