A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Lower respiratory tract infection requiring antibiotics within 4 weeks before Screening or documented acute exacerbation of idiopathic pulmonary fibrosis within 3 months before Screening.
• Active or prior lung cancer.
• Concomitant treatment with more than one locally approved idiopathic pulmonary fibrosis therapy.
• Participation in another investigational drug trial within 3 months or 5 half-lives of that drug, whichever is longer.
• New or unresolved infection within 7 days before Screening or randomization, except respiratory infections addressed separately.
• Use of non permitted concomitant medication as per protocol.
• Documented alcohol or drug abuse within 12 months before Screening.

Más betegség

• Planned major surgery during the study or history of lung resection.
• Active cancer or cancer history with less than 5 years disease-free survival, except adequately treated localized carcinoma.
• End-stage fibrotic disease expected to require organ transplantation within 6 months.
• Clinically relevant uncontrolled medical or psychiatric disorders that may interfere with study completion or increase risk.
• Other non-idiopathic pulmonary fibrosis pulmonary condition that may affect forced vital capacity.
• Clinically significant cardiovascular condition that would preclude participation.
• Significant neurologic disease, including protocol-specified recent transient ischemic attack, stroke, seizure, uncontrolled seizure disorder, or clinically significant behavioral or psychiatric disturbance.
• Recent or current systemic corticosteroid, immunosuppressant, cytotoxic therapy, pulmonary hypertension vasodilator therapy, inhaled bronchodilator, or inhaled corticosteroid use within protocol-specified periods.
• Known intolerance or hypersensitivity to formulation excipients or another substance used in the trial.
• Positive hepatitis test indicating acute or chronic hepatitis B or C at Screening.

Laborértékek

• Clinically significant abnormal 12-lead electrocardiogram; corrected QT interval using Fridericia's formula greater than 450 milliseconds for males or greater than 470 milliseconds for females.
• Clinically relevant abnormal laboratory values requiring investigation or potentially affecting safety or study evaluation.

Egyéb

• Emphysema involving at least 50% of the lung on high-resolution computed tomography or emphysema greater in extent than fibrosis.
• Body mass index reater than or equal to 35.0 kg/m² or recent excessive unexplained weight loss.
• Positive human immunodeficiency virus type 1 or type 2 test at Screening.
• Pregnant or lactating female participant.

• Written informed consent obtained before any study-related procedure.
• Male or female participant of any race, aged 40 years or older.
• Diagnosis of idiopathic pulmonary fibrosis according to the 2018 and 2022 ATS/ERS/JRS/ALAT Guidelines for no more than 8 years before Screening, confirmed by centrally reviewed high-resolution computed tomography obtained within 12 months before Screening or performed during Screening.
• Receiving locally approved idiopathic pulmonary fibrosis monotherapy at a stable dose for at least 8 weeks before Screening, or not receiving such monotherapy, including discontinuation at least 4 weeks before Screening.
• Forced vital capacity at least 45% predicted and pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio at least 0.7.
• Diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, at least 25% predicted.
• Peripheral oxygen saturation greater than 90% after 5 minutes at rest on room air or with protocol-specified supplemental oxygen.
• Ability to correctly use the device after training with placebo.
• Nonsmoker or ex-smoker meeting protocol-defined cessation periods and willing to abstain from all inhaled smoking products throughout the study.
• Female participant meeting protocol definitions for non-childbearing potential or, if of childbearing potential, meeting pregnancy-testing and contraception requirements.
• Male participant meeting protocol-defined fertility and contraception requirements