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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00369993

Enrollment

Registered

2006-08-30

Start date

2005-03-31

Completion date

2005-05-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, spacer

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.

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.

Interventions

DRUGfluticasone propionate/salmeterol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)	—

Secondary

Measure	Time frame
The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate	—

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026