Spacer Comparison In Adult Asthmatics

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 28, 2006
Last updated: September 5, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Drug: fluticasone propionate/salmeterol
Phase 2

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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)

Secondary Outcome Measures:
  • The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate

Enrollment: 20
Study Start Date: March 2005
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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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:

  • Taking oral corticosteroids or inhaled fluticasone propionate
  • Have certain medical conditions or are not otherwise healthy.
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Please refer to this study by its identifier: NCT00369993

New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00369993     History of Changes
Other Study ID Numbers: SAS104449
Study First Received: August 28, 2006
Last Updated: September 5, 2013
Health Authority: New Zealand: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 30, 2015