Last updated: 11/04/2018 04:31:20

ADVAIR DISKUS® (fluticasone propionate/salmeterol) inhaler Versus SEREVENT DISKUS® (salmeterol) inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® inhalers are trademarks of the GSK group of companies.

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GSK study ID
ADC105931
See study documents
Clinicaltrials.gov ID
NCT00346749
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared with Salmeterol DISKUS 50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percent of sputum neutrophils

Timeframe: N/A

Secondary outcomes:

Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms

Timeframe: N/A

Interventions:
Drug: Salmeterol
Drug: Fluticasone Propionate/Salmeterol Combination Product
Enrollment:
180
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
December 2006 to July 2007
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Diagnosis of COPD.
  • Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
  • Current of secondary diagnosis of asthma or current diagnosis of atopy.
  • Other respiratory disorders other than COPD.
Inclusion and exclusion criteria
Inclusion criteria:
  • Diagnosis of COPD.
  • Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
  • Ex-Smokers with at least a 10 pack-year history.
Exclusion criteria:
  • Current of secondary diagnosis of asthma or current diagnosis of atopy.
  • Other respiratory disorders other than COPD.
  • Other inflammatory diseases.
  • Abnormal and clinically significant chest x-ray or ECG.
  • Lung resection surgery within past 1 year.
  • History of cancer not in remission within past 2 years.
  • Serious, uncontrolled disease.
  • Pregnancy or planning to become pregnant during the study.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Durham, North Carolina, United States, 27704
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
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Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
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Location
GSK Investigational Site
Decatur, Georgia, United States, 30030
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
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Location
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
Status
Study Complete
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Location
GSK Investigational Site
Iowa City, Iowa, United States, 52242
Status
Study Complete
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Location
GSK Investigational Site
Gainesville, Florida, United States, 32610
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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

Results overview

Refer to study documents

Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2007-24-07

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

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