Last updated: 11/04/2018 11:18:44
Repeat Dose Study of Fluticasone propionate/salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A repeat dose, randomised, double blind, 2-way crossover study to assess the safety and systemic exposure of an investigational formulation compared to concurrent administration of individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS inhalers in subjects aged 18 - 55 years with mild asthma
Trial description: A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol
Timeframe: Administration occurred over 14 days and tolerability
Secondary outcomes:
Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol
Timeframe: Administration occurred over 14 days and tolerability
Interventions:
Drug: fluticasone propionate/salmeterol
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
GW857238, fluticasone propionate, fluticasone propionate/salmeterol, salbutamol, salmeterol
Collaborators
Not applicable
Study date(s)
January 2005 to April 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- Documented history of mild or intermittent asthma
- Have PEF and FEV1>80% predicted
- Have had a life threatening episode of asthma
- Have had a respiratory tract infection in the last four weeks
Inclusion and exclusion criteria
Inclusion criteria:
- Documented history of mild or intermittent asthma
- Have PEF and FEV1>80% predicted
- Not a smoker
- BMI of 19
- 29
Exclusion criteria:
- Have had a life threatening episode of asthma
- Have had a respiratory tract infection in the last four weeks
- Have other respiratory disease
- Have taken certain medications within restricted time periods
Trial location(s)
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-13-04
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
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Additional information
Results for study SAS10019 can be found on the GSK Clinical Study Register.
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