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

Condition(s) targeted: Asthma

Intervention: TPI-1020 (Drug); budesonide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Topigen Pharmaceuticals

Official(s) and/or principal investigator(s):
Paolo Renzi, MD, Study Director, Affiliation: Topigen Pharmaceuticals

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

Primary outcome: To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke

Secondary outcome:

To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22

To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14

To compare pre-dose FEV1 measurements on multiple days throughout the study

To compare peak flow measurements throughout the study

To compare the use of daily rescue medication (salbutamol) throughout the study

To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

McMaster University Hospital, Hamilton, Ontario L8N 3Z5, Canada

Kingston General Hospital, Kingston, Ontario K7L 106, Canada

Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval, Ste-Foy, Quebec G1V 4G5, Canada

Centre Hospitalier St-Sacrement, Ste-Foy, Quebec G1S 4L8, Canada

Hopital Sacre Coeur, Montreal, Quebec H4J 1G5, Canada

Montreal Chest Institute, Montreal, Quebec H2X 2P4, Canada

CARL, Laval, Quebec H7V 3Y7, Canada

Starting date: May 2006
Ending date: March 2007
Last updated: November 7, 2007