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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269126
• Other study ID #: SCO100646
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: April 11, 2013
• Start date: February 2005
• Est. completion date: August 2005

Study information

• Verified date: May 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis, Chronic
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• fluticasone propionate/salmeterol combination DISKUS

• salmeterol xinafoate

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Kyoto
Spain	GSK Investigational Site	Unknown

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary	Change in morning PEF
Secondary	Changes in pre-dose FVC, V50, V25
Secondary	Use of rescue medication
Secondary	Changes in symptom scores