Last updated: 11/07/2018 19:15:25
A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 100mcg BID Individually and in Combination and Placebo in Subjects with Asthma.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 100mcg BID Individually and in Combination and Placebo in Subjects with Asthma.
Trial description: A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 100mcg BID Individually and in Combination and Placebo in Subjects with Asthma.
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:
Combined salmeterol 50 microg and fluticasone propionate 250 microg in the diskus device for the treatment of asthma. Shapiro, G., Lumry, W., Wolfe, J., Given, J., White, M. V., Woodring, A., Baitinger, L., House, K., Prillaman, B., and Shah, T. Am J Respir Crit Care Med 2000; 161(2 Pt 1):527-34
Edwards T, Gross G, Mitchell D, et al. The salmeterol xinafoate/fluticasone propionate dry powder combination product via Diskus inhaler improves asthma control compared to salmeterol xinafoate or fluticasone propionate dry powder alone (abstract). Am J Respir Crit Care Med 1998; 1587:A414 AM. J. RESPIR. CRIT. CARE MED. 1998;157(3):A414.
Kavuru M, Melamed J, Gross G, LaForce C, House K, Prillaman B, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000;150(6):1108-1116.
Nathan RA, LaForce C, Mitchell D, et al. The salmeterol/fluticasone propionate combination (50/100mcg) via Diskus has a rapid onset of effect in asthma patients on salmeterol or inhaled corticosteroids.AmJ Respir Crit CareMed 1999; 159 (3 Pt 2): A637 AM. J. RESPIR. CRIT. CARE MED. 1999;159(3 PART 2):637
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
August 1996 to June 1997
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
1997-15-06
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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