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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   (Adult)
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

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:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 23, 2016