Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
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.
1 other identifier
interventional
62
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 3, 2012
November 1, 2012
1.1 years
May 23, 2007
November 30, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
42 days
Secondary Outcomes (1)
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.
42 days
Study Arms (3)
TPI 1020
EXPERIMENTALTPI 1020 500 mcg BID x 42 days
Budosenide cortico
ACTIVE COMPARATORBudesonide 800 mcg BID x 42 days
Placebo
PLACEBO COMPARATORPlacebo inhaler
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntaralead
Study Sites (13)
University of alberta Hsopital
Edmonton, Alberta, T6G2B7, Canada
Vancouver Hospital Lung Center
Vancouver, British Columbia, V5Z 1 M9, Canada
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N4A6, Canada
Clinique Medical Les Saules
Les Saules, Quebec, G1P 1J6, Canada
Omnispec Clinical Research Inc.
Mirabel, Quebec, J7J 2K8, Canada
Hopital Thoracique Montreal-CSUM
Montreal, Quebec, H2X2P4, Canada
Hopital Sacre Coeur de Montreal
Montreal, Quebec, H4J1C5, Canada
Kells Medical Research Group
Pointe-Claire, Quebec, H9R 4S3, Canada
Complexe Medicale Langelier
Saint-Léonard, Quebec, H1S 3A9, Canada
Diex Research Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
CHUS -Hopital FLEURIMONT
Sherbrooke, Quebec, J1H5N4, Canada
Centre de Cardiologie et de Pneumologie de l'Université Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois Maltais, MD
Centre de Cardiologie et de Pneumologie de l'Université Laval
- STUDY DIRECTOR
Rene Pageau, M.Sc Pharm
Syntara
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2007
First Posted
June 7, 2007
Study Start
November 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 3, 2012
Record last verified: 2012-11