Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDE/ADVAIR 250HFA MDI alone and with AeroChamber-Max spacer and VOLUMATIC both in their washed and unwashed states in adult subjects with mild or intermittent asthma
Trial description: Spacers are used by people with respiratory diseases who have problems using MDIs (metered dose inhalers). This study used fluticasone propionate/salmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: fluticasone propionate/salmeterol
Enrollment:
20
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
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
March 2005 to May 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Non-smoking with a BMI of 19 - 30
- Diagnosed with mild or intermittent asthma and taking medication for it.
- Taking oral corticosteroids or inhaled fluticasone propionate
- Have certain medical conditions or are not otherwise healthy.
Inclusion and exclusion criteria
Inclusion criteria:
- Non-smoking with a BMI of 19
- 30
- Diagnosed with mild or intermittent asthma and taking medication for it.
Exclusion criteria:
- Taking oral corticosteroids or inhaled fluticasone propionate
- Have certain medical conditions or are not otherwise healthy.
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
2005-24-05
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
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