The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
400 mcg BID x 14 days then 800 mcg/day x 7 more days
McMaster University Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
CARL
Laval, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Time frame: 22 days
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
Time frame: 22 days
To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14
Time frame: 22 days
To compare pre-dose FEV1 measurements on multiple days throughout the study
Time frame: 22 days
To compare peak flow measurements throughout the study
Time frame: 22 days
To compare the use of daily rescue medication (salbutamol) throughout the study
Time frame: 22 days
To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period
Time frame: 22 days
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Hopital Sacre Coeur
Montreal, Quebec, Canada
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, Canada