Asthma
Conditions
Keywords
Smokers, Adults, Inflammatory markers
Brief summary
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
Detailed description
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.
Interventions
DRUGTPI-1020
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
DRUGbudesonide
400 mcg BID x 14 days then 800 mcg/day x 7 more days
Sponsors
Syntara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males or females 18 through 65 years of age. * Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day. * Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1 * History of episodic wheeze and shortness of breath * Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
Exclusion criteria
* History or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator * History of serious adverse reaction or hypersensitivity to corticosteroids * Abnormal chest X-ray that is judged clinically significant * Pregnant or lactating or have positive plasma pregnancy test * Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks. * Use of any other asthma-related medications within 1 month of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14 | 22 days |
| To compare pre-dose FEV1 measurements on multiple days throughout the study | 22 days |
| To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 | 22 days |
| To compare the use of daily rescue medication (salbutamol) throughout the study | 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 | 22 days |
| To compare peak flow measurements throughout the study | 22 days |
Countries
Canada
Outcome results
None listed