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CompletedNCT00369993Updated Oct 17, 2016

Spacer Comparison In Adult Asthmatics

A Phase 2 interventional study of fluticasone propionate/salmeterol in Asthma, sponsored by GlaxoSmithKline. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

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.

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • spacer
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 20 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non-smoking with a BMI of 19 - 30
  • Diagnosed with mild or intermittent asthma and taking medication for it.

Exclusion criteria

Exclusion criteria:

  • Taking oral corticosteroids or inhaled fluticasone propionate
  • Have certain medical conditions or are not otherwise healthy.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Interventions

  • Drugfluticasone propionate/salmeterol
06

What researchers measure

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

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Study locations

1 site
  • GSK Investigational Site
    Wellington, 6035, New Zealand
08

References and documents

Publications

  • This study has not been published in the scientific literature.

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00369993
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 30, 2006
Start date
Mar 2005
Primary completion
May 2005
Completion
May 2005
Last update
Oct 17, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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