Spacer Comparison In Adult Asthmatics
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate/salmeterol (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, BA, MB, BS, PhD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: A Randomised, Open Label, Five-Way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE™/ADVAIR™ 250 HFA MDI Without Spacer and With AeroChamber-Max Spacer and VOLUMATIC™ Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma.
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)
Secondary outcome: The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Wellington 6004, New Zealand
Additional Information
Starting date: March 2005
Last updated: September 11, 2007
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