SERETIDE Plus Tiotropium Versus Individual Components

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00325169
First received: May 10, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Tiotropium + SERETIDE 50/500
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC (0-4hrs, sGAW after morning dose of medication at day 14)

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 48
Study Start Date: December 2005
Intervention Details:
    Drug: Tiotropium + SERETIDE 50/500
    Other Name: Tiotropium + SERETIDE 50/500
Detailed 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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325169

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
United Kingdom
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
GSK Investigational Site
London, United Kingdom, SE5 9RJ
GSK Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00325169     History of Changes
Other Study ID Numbers: SCO104962
Study First Received: May 10, 2006
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Cross-over
Tiotropium
Triple
COPD
SERETIDE 50/500
Dyspnoea
Impulse oscillometry
Plethysmography

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014