Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients - Full Text View

Sponsored by:	Topigen Pharmaceuticals
Information provided by:	Topigen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00483743

Purpose

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.

Condition	Intervention	Phase
COPD Patients	Drug: TPI 1020 Drug: Budesonide Drug: Placebo	Phase II

Drug Information available for: Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Topigen Pharmaceuticals:

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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	November 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TPI 1020 500 mcg BID x 42 days	Drug: TPI 1020 250 mcg/caps 2 caps BID x 42 days
2: Active Comparator Budesonide 800 mcg BID x 42 days	Drug: Budesonide 400mcg mcg capsules- 2 capsules BID
3: Placebo Comparator	Drug: Placebo 2 caps BID x42 days

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483743

Contacts

Contact: Francois Maltais, MD	(418) 656-4747	Francois.Maltais @med.ulaval.ca
Contact: Julie Milot, MD	(418) 656-4747	julie.milot@crhl.ulaval.ca

Locations

Canada, Alberta
University of alberta Hsopital	Active, not recruiting
Edmonton, Alberta, Canada, T6G2B7
Canada, British Columbia
Vancouver Hospital Lung Center	Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1 M9
Canada, Ontario
Firestone Institute for Respiratory Health	Active, not recruiting
Hamilton, Ontario, Canada, L8N4A6
Canada, Quebec
CHUS -Hopital FLEURIMONT	Active, not recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Hopital Thoracique Montreal-CSUM	Active, not recruiting
Montreal, Quebec, Canada, H2X2P4
Centre de Cardiologie et de Pneumologie de l'Université Laval	Recruiting
Ste-Foy, Quebec, Canada, G1V 4G5
Contact: Francois Maltais, M.D 418-656-4747 Francois.Maltais @med.ulaval.ca
Principal Investigator: Francois Maltais, MD
Complexe Medicale Langelier	Active, not recruiting
St-Leonard, Quebec, Canada, H1S 3A9
Hopital Sacre Coeur de Montreal	Active, not recruiting
Montreal, Quebec, Canada, H4J1C5
Omnispec Clinical Research Inc.	Active, not recruiting
Mirabel, Quebec, Canada, J7J 2K8
Clinique Medical Les Saules	Active, not recruiting
Les Saules, Quebec, Canada, G1P 1J6
Diex Research Inc.	Active, not recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Kells Medical Research Group	Active, not recruiting
Pointe-Claire, Quebec, Canada, H9R 4S3
Canada, Saskatchewan
Royal University Hospital	Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

Topigen Pharmaceuticals

Investigators

Principal Investigator:	Francois Maltais, MD	Centre de Cardiologie et de Pneumologie de l'Université Laval
Study Director:	Rene Pageau, M.Sc Pharm	Topigen Pharmaceuticals

More Information

Responsible Party:	Topigen Pharmaceuticals Inc. ( Rene Pageau, Sr Director Clinical Research )
Study ID Numbers:	TPI 1020-203
Study First Received:	May 23, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00483743
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Budesonide
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Peripheral Nervous System Agents
Hormones
Glucocorticoids
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009