SERETIDE Plus Tiotropium Versus Individual Components

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Tiotropium + SERETIDE 50/500

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325169

SCO104962

Details and patient eligibility

About

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

Full description

A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD

Enrollment

41 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has an established clinical history of COPD as defined as per the GOLD definition.
Post-bronchodilator FEV1 of >30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
Current or ex-smoker with a smoking history of > 10 pack-years.

Exclusion criteria

Has unstable COPD (Chronic Obstructive Pulmonary Disease).
Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as > 12 hours oxygen use per day).