Last updated: 11/07/2018 19:15:41
A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulations of salmeterol 50mcg twice daily and fluticasone propionate 500mcg twice daily individually and in combination as compared to placebo in COPD patients.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulations of salmeterol 50mcg twice daily and fluticasone propionate 500mcg twice daily individually and in combination as compared to placebo in COPD patients.
Trial description: A randomized, double-blind, placebo-controlled, parallel-group, trial evaluating the safety and efficacy of the Diskus formulations of salmeterol 50mcg twice daily and fluticasone propionate 500mcg twice daily individually and in combination as compared to placebo in COPD patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Improvements in fev1 and symptoms in copd patients following 24 weeks of twice daily treatment with salmeterol 50/ fluticasone propionate 50 combination. Mahler, D A, Wong, E, Giessel, G, Clifford, D, Chang, C, Yates, J, Fischer, T, Horstman, D, and Wire, P American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Francisco , California
Abstract: Predicting lung function responses to salmeterol/fluticasone propionate combination therapy in copd. Mahler, D. A., Darken, P., Brown, C. P., and Knobil, K. 13th Annual Congress of the European Respiratory Society 9/27/2003 Vienna; Austria
Mahler DA, Wire P, Horstman D, et al. Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 2002;166:1084-1091.
Mahler DA, Wong E, Giessel G, Clifford D, Chang C, Yates J, Fischer T, Horstman D, Wire P. Improvements in FEV1 and symptoms in COPD patients following 24 weeks of twice-daily treatment with salmeterol 50/fluticasone propionate 500 combination. Am J Respir Crit Care Med 2001;163(Suppl 5):A279.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
October 1998 to May 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-05-05
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
Not applicable
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