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

Launched by CHIESI FARMACEUTICI S.P.A. · Dec 14, 2017

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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