Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Product Name: Recombinant truncated SPINT2 Protease inhibitor
Product Code: AER 002
Pharmaceutical Form: Nebuliser solution
Other descriptive name: biku
Sponsors
Aerovance, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) Males or females diagnosed with chronic obstructive pulmonary disease; (b) Aged >40 yrs (c) Subjects who have an FEV1 of 75% or less of predicted at time of screening (d) Subjects who, if female, are not currently pregnant or breast feeding and using medically acceptable methods of contraception, or are post-menopausal or surgically sterile. (e) Subjects who have a pre-study medical history, physical examination, 12 Lead ECG acceptable to the Investigator. (f) Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening. (g) Subjects who are negative for drugs of abuse and alcohol tests at screening. (h) Must be willing and able to participate in the whole study and must provide written informed consent; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (a) Subjects who have ever sought advice from a General Practitioner or counselor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance abuse e.g. solvents. (b) Positive drugs of abuse test result. (c) Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator. (d) Upper or lower respiratory tract infection (excluding otitis media) within 7 days of the first study day (Day 1 of dosing) (requiring antibiotics for that infection) (e) Subjects who have had a change in their COPD medication in the 4 weeks prior to study entry (f) Any other significant disease or condition which may interfere with the compound or outcome of the study e.g. metabolic conditions, renal, cardiac or hepatic conditions. (g) Participation in a clinical research study in the past 3 months (h) Subjects who use ambulatory oxygen >10 hours per day (i) Subjects who have had past lung surgeries for COPD (excluding routine biopsies) (j) Subjects who are currently taking tiotropium bromide (SPIRIVA®) (k) Subjects who are currently not producing a lot of sputum in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of AER 002 on mucociliary clearance rate of a radiolabeled particle from the lungs of patients with COPD after 5 days of treatment with AER 002 (30 mg bid nebulized);Secondary Objective: To determine the effects of AER 002 on symptoms (cough, breathlessness, sputum production, oxygen use and general feeling), sputum production while in the clinic, spirometry (FEV1, FVC, PEF, small airways resistance as measured by impedance osillometry). ;Primary end point(s): Effects of AER 002 on mucociliary clearance in patients with COPD. | — |
Countries
United Kingdom
Outcome results
None listed