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

Syntara

Status and phase: Completed; Phase 2

Conditions: Copd Bronchitis

Treatments: Drug: Placebo; Drug: Budesonide; Drug: TPI 1020

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483743

TPI 1020-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 3 patient groups, including a placebo group

TPI 1020

Experimental group

Description:

TPI 1020 500 mcg BID x 42 days

Treatment:

Drug: TPI 1020

Budosenide cortico

Active Comparator group

Description:

Budesonide 800 mcg BID x 42 days

Treatment:

Drug: Budesonide

Placebo

Placebo Comparator group

Description:

Placebo inhaler

Treatment:

Drug: Placebo