Status:
COMPLETED
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
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal bronchodilation afte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03378648
Start Date
December 28 2017
End Date
April 16 2019
Last Update
May 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medicines Evaluation Unit
Manchester, United Kingdom