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

Syntara

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: budesonide

Drug: TPI-1020

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327808

TPI 1020-202

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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