Status:
COMPLETED
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
Lead Sponsor:
Syntara
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00327808
Start Date
May 1 2006
End Date
March 1 2007
Last Update
December 3 2012
Active Locations (7)
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1
McMaster University Hospital
Hamilton, Ontario, Canada, L8N 3Z5
2
Kingston General Hospital
Kingston, Ontario, Canada, K7L 106
3
CARL
Laval, Quebec, Canada, H7V 3Y7
4
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4