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Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients

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ClinicalTrials.gov Identifier: NCT00483743
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : December 3, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Copd Bronchitis Drug: TPI 1020 Drug: Budesonide Drug: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis
Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TPI 1020
TPI 1020 500 mcg BID x 42 days
Drug: TPI 1020
250 mcg/caps 2 caps BID x 42 days
Active Comparator: Budosenide cortico
Budesonide 800 mcg BID x 42 days
Drug: Budesonide
400mcg mcg capsules- 2 capsules BID
Placebo Comparator: Placebo
Placebo inhaler
Drug: Placebo
2 caps BID x42 days


Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 42 days ]

Secondary Outcome Measures :
  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. [ Time Frame: 42 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483743


Locations
Canada, Alberta
University of alberta Hsopital
Edmonton, Alberta, Canada, T6G2B7
Canada, British Columbia
Vancouver Hospital Lung Center
Vancouver, British Columbia, Canada, V5Z 1 M9
Canada, Ontario
Firestone Institute for Respiratory Health
Hamilton, Ontario, Canada, L8N4A6
Canada, Quebec
Clinique Medical Les Saules
Les Saules, Quebec, Canada, G1P 1J6
Omnispec Clinical Research Inc.
Mirabel, Quebec, Canada, J7J 2K8
Hopital Thoracique Montreal-CSUM
Montreal, Quebec, Canada, H2X2P4
Hopital Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Kells Medical Research Group
Pointe-Claire, Quebec, Canada, H9R 4S3
Diex Research Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
CHUS -Hopital FLEURIMONT
Sherbrooke, Quebec, Canada, J1H5N4
Complexe Medicale Langelier
St-Leonard, Quebec, Canada, H1S 3A9
Centre de Cardiologie et de Pneumologie de l'Université Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: Francois Maltais, MD Centre de Cardiologie et de Pneumologie de l'Université Laval
Study Director: Rene Pageau, M.Sc Pharm Pharmaxis
More Information

Responsible Party: Pharmaxis
ClinicalTrials.gov Identifier: NCT00483743     History of Changes
Other Study ID Numbers: TPI 1020-203
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists