Last updated: 11/07/2018 18:44:48
A 16-week, randomized, double-blind, double-dummy, placebo-controlled, 4-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of fluticasone propionate and salmeterol administered via FP/Salmeterol (SALM) combination product Diskus (FP 250mcg/SALM 50mcg), FP/Salmeterol combination metered dose inhaler (MDI) (FP 110mcg/SALM 21mcg) containing the hydrofluoroalkane (HFA) propellant, GR106642X, and FP MDI (FP 110mcg) containing HFA propellant
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 16-week, randomized, double-blind, double-dummy, placebo-controlled, 4-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of fluticasone propionate and salmeterol administered via FP/Salmeterol (SALM) combination product Diskus (FP 250mcg/SALM 50mcg), FP/Salmeterol combination metered dose inhaler (MDI) (FP 110mcg/SALM 21mcg) containing the hydrofluoroalkane (HFA) propellant, GR106642X, and FP MDI (FP 110mcg) containing HFA propellant
Trial description: A 16-week, randomized, double-blind, double-dummy, placebo-controlled, 4-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of fluticasone propionate and salmeterol administered via FP/Salmeterol (SALM) combination product Diskus (FP 250mcg/SALM 50mcg), FP/Salmeterol combination metered dose inhaler (MDI) (FP 110mcg/SALM 21mcg) containing the hydrofluoroalkane (HFA) propellant, GR106642X, and FP MDI (FP 110mcg) containing HFA propellant
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: Dose proportionality and in vivo performa strengths (50125, 125125, and 250125 propionate/salmeterol metered-dose inhalers in healthy subjects. SMS Andrews, RL Kunka, Y Yin, Karen Callahan, M York, PT Daley-Yates. 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002 New York NY
Abstract: Lower systemic exposure and reduced systemic pharmacodynamic effects from a combination salmeterol/fluticasone propionate metered-dose inhaler compared individual inhalers in healthy subjects. RL Kunka, Y Yin, SMS Andrews, M Yorkas, Karen Callahan, Kirby, Daley-Yates. 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
Collaborators
Not applicable
Study date(s)
May 2003 to November 2003
Type
Not applicable
Phase
1
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
2003-21-11
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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