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OpenTrials
Completed

NCT Number: NCT00369993

Spacer Comparison In Adult Asthmatics

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Wellington, 6035, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluticasone propionate/salmeterol

Drug

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 30, 2006
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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