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Completed

NCT Number: NCT00325169

SERETIDE Plus Tiotropium Versus Individual Components

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Ghent, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tiotropium + SERETIDE 50/500

Drug

Primary outcomes

  1. AUC (0-4hrs, sGAW after morning dose of medication at day 14)

Secondary outcomes

  1. Effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments on further elements of lung function, dyspnoea, symptoms and a patient/physician assessment of treatment effect.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomised, Double-blind, Double Dummy, 3 Way Crossover Study Evaluating the Effects of a Combination of Seretide 50/500mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Agents (Tiotropium Bromide 18mcg Alone and Seretide50/500mcg Alone) in the Treatment of Subjects With COPD

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 12, 2006
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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