Back to resultsInhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
TPI-1020
budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Smokers, Adults, Inflammatory markers
Eligibility 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
Sites / Locations
- McMaster University Hospital
- Kingston General Hospital
- CARL
- Montreal Chest Institute
- Hopital Sacre Coeur
- Centre Hospitalier St-Sacrement
- Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inhaler
Inhaler cortico.
Arm Description
TPI 1020
Budesonide inhaler
Outcomes
Primary Outcome Measures
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327808
Brief Title
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmaxis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Smokers, Adults, Inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhaler
Arm Type
Experimental
Arm Description
TPI 1020
Arm Title
Inhaler cortico.
Arm Type
Active Comparator
Arm Description
Budesonide inhaler
Intervention Type
Drug
Intervention Name(s)
TPI-1020
Intervention Description
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Description
400 mcg BID x 14 days then 800 mcg/day x 7 more days
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Time Frame
22 days
Secondary Outcome Measure Information:
Title
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
Time Frame
22 days
Title
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
Title
To compare pre-dose FEV1 measurements on multiple days throughout the study
Time Frame
22 days
Title
To compare peak flow measurements throughout the study
Time Frame
22 days
Title
To compare the use of daily rescue medication (salbutamol) throughout the study
Time Frame
22 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Renzi, MD
Organizational Affiliation
Pharmaxis
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 106
Country
Canada
Facility Name
CARL
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 3Y7
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Hopital Sacre Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1G5
Country
Canada
Facility Name
Centre Hospitalier St-Sacrement
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
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Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
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