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Completed

NCT Number: NCT00465413

Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler

The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mackay Memorial Tamshui Branch Hospital, Tamshui, Taipei, Taiwan

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About this study

Administration of bronchodilator drugs with metered-dose inhalers (MDIs) is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly. Use of spacers seems to improve delivery in these patients. It is not clear, however, if there is any advantage to a spacer for patients who are able to use an MDI with correct technique.

The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations. The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator (2 puffs, 0.4 mg of fenoterol). Spirometry is performed before and after the inhalation.

The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement.

The outcome to be measured is the increase in forced expiratory volume in 1 second (FEV1) and forced expiratory flow rate (FEF25-75%).

Who can participate

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

Inclusion criteria

  • age > 6 years old,
  • subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry.

Exclusion criteria

  • refusal to participate,
  • negative bronchodilator test,
  • poor performance of pulmonary function testing.

Treatment and study plan

Small volume spacer and/or Rinsing the mouth with water

Device

Primary outcomes

  1. forced expiratory volume in 1 second (FEV1)

  2. forced expiratory flow rate (FEF25-75%)

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Acronym: MDI

Important dates

Study start
2004
First posted
Apr 25, 2007
Registry last updated
Nov 14, 2007

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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