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.

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.

Study Overview

• Status: Completed
• Conditions: Copd Bronchitis
• Intervention / Treatment: Drug: TPI 1020; Drug: Budesonide; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2B7
      • University of alberta Hsopital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1 M9
      • Vancouver Hospital Lung Center
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • Firestone Institute for Respiratory Health
  • Quebec
    • Les Saules, Quebec, Canada, G1P 1J6
      • Clinique Medical Les Saules
    • Mirabel, Quebec, Canada, J7J 2K8
      • Omnispec clinical research inc.
    • Montreal, Quebec, Canada, H2X2P4
      • Hopital Thoracique Montreal-CSUM
    • Montreal, Quebec, Canada, H4J1C5
      • Hopital Sacre Coeur de Montreal
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Kells Medical Research Group
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Inc.
    • Sherbrooke, Quebec, Canada, J1H5N4
      • CHUS -Hopital FLEURIMONT
    • St-Leonard, Quebec, Canada, H1S 3A9
      • Complexe Medicale Langelier
    • Ste-Foy, Quebec, Canada, G1V 4G5
      • Centre de Cardiologie et de Pneumologie de l'Université Laval
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (ESTIMATE): June 7, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: TPI 1020-203