Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmaxis
Treatments:
Budesonide
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.