Last updated: 11/07/2018 18:43:59
A Four-Period Crossover, Placebo Controlled Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of Salmeterol/Fluticasone Propionate/HFA134A via MDI in Combination Compared With Salmeterol/P11/12 and Fluticasone Propionate/P11/12 via MDI Administered Individually.
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 Four-Period Crossover, Placebo Controlled Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of Salmeterol/Fluticasone Propionate/HFA134A via MDI in Combination Compared With Salmeterol/P11/12 and Fluticasone Propionate/P11/12 via MDI Administered Individually.
Trial description: A Four-Period Crossover, Placebo Controlled Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of Salmeterol/Fluticasone Propionate/HFA134A via MDI in Combination Compared With Salmeterol/P11/12 and Fluticasone Propionate/P11/12 via MDI Administered Individually.
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: 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 York, Karen Callahan, Kirby, Daley-Yates, ' 58th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/1/2002 New York NY
Kunka RL, Yin Y, Andrews SMS, York M, Kirby S, Callejas S, and Daley-Yates PT, “Lower Systemic Exposure and Reduced Systemic Pharmacodynamic Effects From a Combination Salmeterol/Fluticasone Propionate Metered-Dose Inhaler Compared to Individual Inhalers in Healthy Subjects”, Presented at American College of Allergy, Asthma and Immunology (ACAAI), New York, March 2002
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
January 1999 to February 1999
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
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
1999-15-02
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
Not applicable
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