Last updated: 11/07/2018 18:45:40
Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Compare the Relative Bioavailability and Pharmacodymanics of Fluticasone Propionate from Two Batches of Seretide MDI with Different in vitro Characteristics
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Compare the Relative Bioavailability and Pharmacodymanics of Fluticasone Propionate from Two Batches of Seretide MDI with Different in vitro Characteristics
Trial description: Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Compare the Relative Bioavailability and Pharmacodymanics of Fluticasone Propionate from Two Batches of Seretide MDI with Different in vitro Characteristics
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:
Edin HM, Lang ML, Vandermeer AK, House KW, Shah TP. Fluticasone propionate/salmeterol Diskus combination product improves asthma-related quality of life compared with individual components in asthma patients symptomatic on ?2 agonists alone. J Allergy Clin Immunol 2002; 109 (1): S241
Lange ML, House KW, Scott A, Shah TP, Akveld MLM. The salmeterol/fluticasone propionate combination 50/100mcg bid is effective as initial maintenance therapy in mild and moderate asthmatics. Eur Respir J 2001; 18 (Suppl 33): 263s
Rosenthal RR, Blake K, Strek M, Lange M, House KW, Vandermeer AK, et al. Fluticasone propionate/salmeterol Diskus combination product provides superior asthma control compared with fluticasone propionate and salmeterol alone in patients previously receiving PRN short-acting beta-2-agonists alone. J Allergy Clin Immunol 2002; 109 (1): S245
Schoaf L, Emmett A, House K, Matthews T, Dorinsky P. Treatment response to fluticasone propionate/salmeterol combination product in three ethnic groups. Am J Respir Crit Care Med 2002; 165 (8): A568
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
March 2003 to May 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
2003-17-05
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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