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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483743

Enrollment

Registered

2007-06-07

Start date

2007-11-30

Completion date

2008-12-31

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd Bronchitis

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.

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.

Interventions

DRUGTPI 1020

250 mcg/caps 2 caps BID x 42 days

DRUGBudesonide

400mcg mcg capsules- 2 capsules BID

DRUGPlacebo

2 caps BID x42 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026