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

Tracking Information

First Received Date ^ICMJE

May 17, 2006

Last Updated Date

November 7, 2007

Start Date ^ICMJE

May 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke [ Time Frame: 22 days ]

Original Primary Outcome Measures ^ICMJE

To determine the safety and tolerability of multiple doses of TPI 1020 in subjects with asthma who smoke.

Change History

Complete list of historical versions of study NCT00327808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22 [ Time Frame: 22 days ]
To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14 [ Time Frame: 22 days ]
To compare pre-dose FEV1 measurements on multiple days throughout the study [ Time Frame: 22 days ]
To compare peak flow measurements throughout the study [ Time Frame: 22 days ]
To compare the use of daily rescue medication (salbutamol) throughout the study [ Time Frame: 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 [ Time Frame: 22 days ]

Original Secondary Outcome Measures ^ICMJE

To compare sputum neutrophil and eosinophil counts on Day 0 vs. Day 15 and Day 22
To determine pharmacodynamic effects on 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 PK profile on a sub-group of subjects on first and last day of the dosing period. .

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: TPI-1020
Drug: budesonide

Study Arms / Comparison Groups

Experimental: TPI 1020
Active Comparator: Budesonide inhaler

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00327808

Responsible Party

Study ID Numbers ^ICMJE

TPI 1020-202

Study Sponsor ^ICMJE

Topigen Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paolo Renzi, MD

Topigen Pharmaceuticals

Information Provided By

Topigen Pharmaceuticals

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP