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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmaxis
• Treatments: Budesonide

Criteria

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