Spacer Comparison In Adult Asthmatics

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369993
• Other study ID #: SAS104449
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2006
• Last updated: October 13, 2016
• Start date: March 2005
• Est. completion date: May 2005

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone propionate/salmeterol

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

New Zealand, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)
Secondary	The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate

External Links

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