A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Part 1
male subjects aged 18-55 years inclusive;
healthy subjects based on medical evaluation including medical history,physical examination, laboratory tests and cardiac testing
Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 extremes 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;
Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
Lung function equal to or more than 80% of predicted normal value and FEV1/FVC ratio \> 0.70;
Part 2
Adult male and female subjects aged 18 to 75 years
Clinical diagnosis of mild persistent asthma
FEV1 reversibility of ≥ 12% or 200 ml over the baseline value starting within 30 mins after inhalation of 400 micrograms of salbutamol
Patients who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
Part 3
Male aged between 40 and 75 years
Stable patients with a post-bronchodilator 40% ≤ FEV1 \< 80% of the predicted normal value, post-bronchodilator FEV1/FVC \< 0.7 with salbutamol
Current smokers and ex-smokers
Response to ipratropium bromide defined as an increase in FEV1 of \> 7 % starting 30 minutes after inhalation of 80 micrograms ipratropium bromide
Response to salbutamol defined an increase in FEV1 of \> 7 % starting 15 minutes to 30 min following inhalation of 400 micrograms salbutamol MDI
You may not be if
Part1
Any clinically relevant abnormabilites and/or uncontrolled diseases
Abnormal laboratory values
Recent respiratory tract infection
Hypersensitivity to the drug excipients
Positive serology results
Positive cotinine, alcohol, drug of abuse tests
Part 2
Pregnant and/or breast-feeding women
Subjects with a medical history or current diagnosis of COPD or any other pulmonary disease other than asthma
Subjects who have cardiovascular condition
Clinically significant laboratory abnormalities
Subject with serum potassium level below the lower limit of the laboratory reference range
History of alcohol, substance or drug abuse
Hypersensitivity to the drug excipients
Part 3
Female patients
Current diagnosis of asthma or allergic rhinitis or other atopic disease
Recent COPD exacerbations or a lower respiratory tract infection
Hypersensitivity to drug excipients;
Abuse of substance or drug t or with a positive urine drug screen
Unstable concurrent disease
Subjects who have cardiovascular condition
Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease
Patients with serum potassium levels below the lower limit of the laboratory normal range
Clareo Health | A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366
