Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

Multi-Center, Randomized, Double-Blind, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma

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.

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