Last updated: 11/04/2018 11:40:47
Chronic Obstructive Pulmonary Disease Endpoints Study
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind placebo-controlled study of treatments with salmeterol, fluticasone propionate and their combination to evaluate novel endpoints in patients with chronic obstructive pulmonary disease
Trial description: This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
Drug: Fluticasone Propionate 500mcg
Drug: Salmeterol 50mcg
Enrollment:
163
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
March 2006 to February 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Diagnosis of COPD
- Current or ex-smoker at least 10 pack- years
- Diagnosis of asthma
- Active respiratory disorder other than COPD
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of COPD
- Current or ex-smoker at least 10 pack- years
Exclusion criteria:
- Diagnosis of asthma
- Active respiratory disorder other than COPD
- Evidence of clinically significant uncontrolled non-pulmonary disease
- Carcinoma not in complete remission for last 5 years
- Lung volume reduction surgery in previous 12 months
- Nocturnal positive pressure for sleep apnea
- Other inclusion and exclusion criteria will be evaluated at the first study visit.
Trial location(s)
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Absecon, New Jersey, United States, 8201
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
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
Not applicable
Actual study completion date
2007-13-02
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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