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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: TPI-1020; Drug: budesonide

• Registration Number: NCT00327808
• Lead Sponsor: Syntara

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 subjects.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-19
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-30
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaler	TPI-1020	TPI 1020
Inhaler cortico.	budesonide	Budesonide inhaler

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke	22 days

Secondary Outcome Measures

Name	Time	Method
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22	22 days
To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14	22 days
To compare pre-dose FEV1 measurements on multiple days throughout the study	22 days
To compare peak flow measurements throughout the study	22 days
To compare the use of daily rescue medication (salbutamol) throughout the study	22 days
To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period	22 days

Trial Locations

Locations (7)

Montreal Chest Institute; 🇨🇦 Montreal, Quebec, Canada

McMaster University Hospital; 🇨🇦 Hamilton, Ontario, Canada

CARL; 🇨🇦 Laval, Quebec, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Hopital Sacre Coeur; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier St-Sacrement; 🇨🇦 Ste-Foy, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval; 🇨🇦 Ste-Foy, Quebec, Canada