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

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ClinicalTrials.gov Identifier: NCT00269126
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: fluticasone propionate/salmeterol combination DISKUS Drug: salmeterol xinafoate Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description
Study Start Date : February 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: fluticasone propionate/salmeterol combination DISKUS
  • Drug: salmeterol xinafoate
    Other Name: fluticasone propionate/salmeterol combination DISKUS

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

Secondary Outcome Measures :
  1. Change in morning PEF
  2. Changes in pre-dose FVC, V50, V25
  3. Use of rescue medication
  4. Changes in symptom scores

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269126


Locations
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Japan
GSK Investigational Site
Kyoto, Japan, 602-8026
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00269126    
Other Study ID Numbers: SCO100646
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: May 2012
Keywords provided by GlaxoSmithKline:
COPD
Chronic Bronchitis
Emphysema
Additional relevant MeSH terms:
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Bronchitis
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Infections
Bronchial Diseases
Fluticasone
Xhance
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists