PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers

Inclusion criteria

• . Subject's written informed consent obtained prior to any study-related procedure;
• . Male and female subjects aged 40 to 80 years inclusive at screening;
• . Ability to understand the study procedures and the risks involved, and ability to be trained to use the inhalers correctly and to generate sufficient peak inspiratory flow (PIF, at least 40 L/min) using the In-Check device set as per NEXThaler® inhaler resistance;
• . Subjects must weigh at least 45kg for females and 50 kg for males to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2 inclusive;
• . Non- or ex-smokers who smoked \< 5 pack years (pack years = the number of cigarette packs per day times the number of years) and stopped smoking \> 1 year prior to screening;
• . Oral body temperature \< 37.5°C;
• . Mean values of triplicate recording of 12-lead digitised electrocardiogram (ECG) considered as normal (40 beats per min \[bpm\] ≤ heart rate \[HR\] ≤ 110 bpm, 120 ms ≤ PR interval \[PR\] ≤ 210 ms, QRS interval \[QRS\] ≤ 120 ms, QT interval corrected using Fridericia's formula \[QTcF\] ≤ 450 ms for males and QTcF ≤ 470 ms for females);
• . Lung function measurements within normal limits at screening: forced expiratory volume within the first second (FEV1) \> 80% predicted and FEV1/Forced vital capacity (FVC) ratio \> 0.70;

Exclusion criteria