Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Information source: Topigen Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD Patients
Intervention: TPI 1020 (Drug); Budesonide (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Topigen Pharmaceuticals Official(s) and/or principal investigator(s):
Francois Maltais, MD, Principal Investigator, Affiliation: Centre de Cardiologie et de Pneumologie de l'Université Laval
Rene Pageau, M.Sc Pharm, Study Director, Affiliation: Topigen Pharmaceuticals
Overall contact:
Francois Maltais, MD, Phone: (418) 656-4747, Email: Francois.Maltais @med.ulaval.ca
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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.
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Francois Maltais, MD, Phone: (418) 656-4747, Email: Francois.Maltais @med.ulaval.ca
University of alberta Hsopital, Edmonton, Alberta T6G2B7, Canada; Recruiting
Irwin Mayers, MD, Phone: 780-407-1854, Email: imayers@ualberta.ca
Irvin Mayers, MD, Principal Investigator
Vancouver Hospital Lung Center, Vancouver, British Columbia V5Z 1 M9, Canada; Recruiting
Jeremy Road, MD, Phone: 604-875-4122, Email: Jeremy.road@vch.ca
Jeremy Road, MD, Principal Investigator
Firestone Institute for Respiratory Health, Hamilton, Ontario L8N4A6, Canada; Recruiting
Param Nair, MD, Phone: 905-522-1155, Ext: 35044, Email: parames@mcmaster.ca
Param Nair, MD, Principal Investigator
Centre de Cardiologie et de Pneumologie de l'Université Laval, Ste-Foy, Quebec G1V 4G5, Canada; Recruiting
Francois Maltais, M.D, Phone: 418-656-4747, Email: Francois.Maltais @med.ulaval.ca
Francois Maltais, MD, Principal Investigator
Hopital Thoracique Montreal-CSUM, Montreal, Quebec H2X2P4, Canada; Recruiting
Jean Bourbeau, MD, Phone: 514-842-5901, Email: jean.bourbeau@mcgill.ca
Jean Bourbeau, MD, Principal Investigator
CHUS -Hopital FLEURIMONT, Sherbrooke, Quebec J1H5N4, Canada; Recruiting
Pierre Larivee, MD, Phone: 819-346-1110, Ext: 14881, Email: Pierre.Larivee@Usherbrooke.ca
Pierre Larivee, MD, Principal Investigator
Complexe Medicale Langelier, St-Leonard, Quebec H1S 3A9, Canada; Recruiting
Guiseppe Mazza, MD, Phone: 514 253 9191, Email: mazza.pi@bellnet.ca
Guisseppe Mazza, MD, Principal Investigator
Hopital Sacre Coeur de Montreal, Montreal, Quebec H4J1C5, Canada; Recruiting
Simon Parenteau, MD, Phone: 514-338-2162, Email: simonparenteau@videotron.ca
Simon Parenteau, MD, Principal Investigator
Omnispec Clinical Research Inc., Mirabel, Quebec J7J 2K8, Canada; Recruiting
Guy Tellier, MD, Phone: 450-420-0270, Ext: 222, Email: gtellier@ominispec.ca
Guy Tellier, MD, Principal Investigator
Clinique Medical Les Saules, Les Saules, Quebec G1P 1J6, Canada; Recruiting
Jean Roy, MD, Phone: 418-871-1443, Email: cmls@bellnet.ca
Jean Roy, MD, Principal Investigator
Diex Research Inc., Sherbrooke, Quebec J1H 1Z1, Canada; Recruiting
Ginette Girard, MD, Phone: 819-346-2887, Email: ggirard@diex.ca
Ginette Girard, MD, Principal Investigator
Kells Medical Research Group, Pointe-Claire, Quebec H9R 4S3, Canada; Recruiting
Janette Janzen, MD, Phone: 514-694-9940
Janette Janzen, MD, Principal Investigator
Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8, Canada; Recruiting
Darcy Marciniuk, MD, Phone: Tel: 306-966-8298, Email: Darcy.Marciniuk@usask.ca
Darcy Marciniuk, MD, Principal Investigator
Additional Information
Starting date: November 2007
Last updated: August 5, 2008
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