Back to resultsSafety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Primary Purpose
Copd Bronchitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
TPI 1020
Budesonide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Copd Bronchitis
Eligibility Criteria
Inclusion Criteria:
- Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
- Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD
Exclusion Criteria:
- COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
- Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
Sites / Locations
- University of alberta Hsopital
- Vancouver Hospital Lung Center
- Firestone Institute for Respiratory Health
- Clinique Medical Les Saules
- Omnispec Clinical Research Inc.
- Hopital Thoracique Montreal-CSUM
- Hopital Sacre Coeur de Montreal
- Kells Medical Research Group
- Diex Research Inc.
- CHUS -Hopital FLEURIMONT
- Complexe Medicale Langelier
- Centre de Cardiologie et de Pneumologie de l'Université Laval
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
TPI 1020
Budosenide cortico
Placebo
Arm Description
TPI 1020 500 mcg BID x 42 days
Budesonide 800 mcg BID x 42 days
Placebo inhaler
Outcomes
Primary Outcome Measures
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.
Secondary Outcome Measures
Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483743
Brief Title
Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Official Title
Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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
This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.
Detailed Description
A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TPI 1020
Arm Type
Experimental
Arm Description
TPI 1020 500 mcg BID x 42 days
Arm Title
Budosenide cortico
Arm Type
Active Comparator
Arm Description
Budesonide 800 mcg BID x 42 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhaler
Intervention Type
Drug
Intervention Name(s)
TPI 1020
Intervention Description
250 mcg/caps 2 caps BID x 42 days
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
400mcg mcg capsules- 2 capsules BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 caps BID x42 days
Primary Outcome Measure Information:
Title
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD
Exclusion Criteria:
COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Maltais, MD
Organizational Affiliation
Centre de Cardiologie et de Pneumologie de l'Université Laval
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rene Pageau, M.Sc Pharm
Organizational Affiliation
Pharmaxis
Official's Role
Study Director
Facility Information:
Facility Name
University of alberta Hsopital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Vancouver Hospital Lung Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1 M9
Country
Canada
Facility Name
Firestone Institute for Respiratory Health
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Clinique Medical Les Saules
City
Les Saules
State/Province
Quebec
ZIP/Postal Code
G1P 1J6
Country
Canada
Facility Name
Omnispec Clinical Research Inc.
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Hopital Thoracique Montreal-CSUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X2P4
Country
Canada
Facility Name
Hopital Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Kells Medical Research Group
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Diex Research Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
CHUS -Hopital FLEURIMONT
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Complexe Medicale Langelier
City
St-Leonard
State/Province
Quebec
ZIP/Postal Code
H1S 3A9
Country
Canada
Facility Name
Centre de Cardiologie et de Pneumologie de l'Université Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
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Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
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