Last updated: 11/07/2018 18:44:12

A Double-Blind, Placebo-Controlled Four Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Fluticasone Propionate and Salmeterol With Increasing Dose Strengths of the Fluticasone Propionate/Salmeterol/HFA134A MDI Combination Product

GSK study ID
SAS10003
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Double-Blind, Placebo-Controlled Four Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Fluticasone Propionate and Salmeterol With Increasing Dose Strengths of the Fluticasone Propionate/Salmeterol/HFA134A MDI Combination Product
Trial description: A Double-Blind, Placebo-Controlled Four Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Fluticasone Propionate and Salmeterol With Increasing Dose Strengths of the Fluticasone Propionate/Salmeterol/HFA134A MDI Combination Product
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
Kunka RL, Andrews SMS, Yin Y, Callejas S, York M, and Daley-Yates PT, “Dose Proportionality and In Vivo Performance for Three Strengths (50/25, 125/25, and 250/25) of Fluticasone Propionate/Salmeterol Metered-Dose Inhalers in Healthy Subjects”, Presented at American College of Allergy, Asthma and Immunology (ACAAI), New York, March 2002
Medical condition
Respiratory Disorders
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
March 1999 to April 1999
Type
Not applicable
Phase
1

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
1999-19-04

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

Not applicable
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