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

November 30, 2012 updated by: Pharmaxis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Hospital
      • Kingston, Ontario, Canada, K7L 106
        • Kingston General Hospital
    • Quebec
      • Laval, Quebec, Canada, H7V 3Y7
        • Carl
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute
      • Montreal, Quebec, Canada, H4J 1G5
        • Hopital Sacre Coeur
      • Ste-Foy, Quebec, Canada, G1S 4L8
        • Centre Hospitalier St-Sacrement
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaler
TPI 1020
Drug: TPI-1020
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
Active Comparator: Inhaler cortico.
Budesonide inhaler
Drug: budesonide
400 mcg BID x 14 days then 800 mcg/day x 7 more days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
Time Frame: 22 days
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
22 days
To compare pre-dose FEV1 measurements on multiple days throughout the study
Time Frame: 22 days
22 days
To compare peak flow measurements throughout the study
Time Frame: 22 days
22 days
To compare the use of daily rescue medication (salbutamol) throughout the study
Time Frame: 22 days
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
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Investigators

  • Study Director: Paolo Renzi, MD, Pharmaxis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 19, 2006

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI 1020-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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