Last updated: 02/14/2020 20:40:05

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

GSK study ID
SCO100646
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: See Detailed Description
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: fluticasone propionate/salmeterol combination DISKUS
Drug: salmeterol xinafoate
Enrollment:
150
Observational study model:
Not applicable
Primary completion date:
2006-16-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
February 2005 to January 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
  • Diagnosis of COPD.
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Hokkaido, Japan, 006-8555
Status
Study Complete
Location
GSK Investigational Site
Kyoto, Japan, 602-8026
Status
Study Complete
Location
GSK Investigational Site
Kyoto, Japan, 607-8062
Status
Study Complete
Location
GSK Investigational Site
Nara, Japan, 632-8552
Status
Study Complete
Location
GSK Investigational Site
Osaka, Japan, 530-8480
Status
Study Complete
Location
GSK Investigational Site
Osaka, Japan, 596-8501
Status
Study Complete
Location
GSK Investigational Site
Unknown, Japan
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2006-16-01
Actual study completion date
2006-16-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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