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Completed

NCT Number: NCT00269126

Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Kyoto, Japan

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About this study

Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of COPD.

Exclusion criteria

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.

Treatment and study plan

fluticasone propionate/salmeterol combination DISKUS

Drug

Salmeterol xinafoate

Drug

Other names: fluticasone propionate/salmeterol combination DISKUS

Primary outcomes

  1. Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg

Secondary outcomes

  1. Change in morning PEF

  2. Changes in pre-dose FVC, V50, V25

  3. Use of rescue medication

  4. Changes in symptom scores

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

See Detailed Description

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 23, 2005
Registry last updated
Apr 15, 2013

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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