Last updated: 11/04/2018 11:56:59
Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Multi-centre, DB, R and stratified parallel group study to compare the efficacy and safety of FP 500mcg bid vs. SRT 50/250mcg via diskus in COPD pts with partial reversible obstruction
Trial description: Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.
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 250/50 DISKUS combination product
Drug: fluticasone propionate DISKUS 500mcg
Enrollment:
290
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)
November 2003 to April 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Established history of chronic obstructive pulmonary disease (COPD).
- Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
- History of asthma or allergy.
- Unstable COPD in the 3 months before the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Established history of chronic obstructive pulmonary disease (COPD).
- Lung function parameters: FEV1/FVC ratio < 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
- Signed and dated informed consent.
Exclusion criteria:
- History of asthma or allergy.
- Unstable COPD in the 3 months before the study.
- Interference of non-pulmonary medication or diseases with COPD outcome parameters.
Trial location(s)
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
Not applicable
Actual study completion date
2006-20-04
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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