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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00483743
First received: May 23, 2007
Last updated: November 30, 2012
Last verified: November 2012

May 23, 2007
November 30, 2012
November 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00483743 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Copd Bronchitis
  • Drug: TPI 1020
    250 mcg/caps 2 caps BID x 42 days
  • Drug: Budesonide
    400mcg mcg capsules- 2 capsules BID
  • Drug: Placebo
    2 caps BID x42 days
  • Experimental: TPI 1020
    TPI 1020 500 mcg BID x 42 days
    Intervention: Drug: TPI 1020
  • Active Comparator: Budosenide cortico
    Budesonide 800 mcg BID x 42 days
    Intervention: Drug: Budesonide
  • Placebo Comparator: Placebo
    Placebo inhaler
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00483743
TPI 1020-203
No
Pharmaxis
Pharmaxis
Not Provided
Principal Investigator: Francois Maltais, MD Centre de Cardiologie et de Pneumologie de l'Université Laval
Study Director: Rene Pageau, M.Sc Pharm Pharmaxis
Pharmaxis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP