Spacer Comparison In Adult Asthmatics
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
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Mar 2005
Shorter than P25 for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 30, 2006
CompletedOctober 17, 2016
October 1, 2016
2 months
August 28, 2006
October 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)
Secondary Outcomes (1)
The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate
Interventions
Eligibility Criteria
You may qualify if:
- Non-smoking with a BMI of 19 - 30
- Diagnosed with mild or intermittent asthma and taking medication for it.
You may not qualify if:
- Taking oral corticosteroids or inhaled fluticasone propionate
- Have certain medical conditions or are not otherwise healthy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Wellington, 6035, New Zealand
Related Publications (1)
This study has not been published in the scientific literature.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2006
First Posted
August 30, 2006
Study Start
March 1, 2005
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
October 17, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.