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

This study has been completed.
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00465413
First received: April 24, 2007
Last updated: November 13, 2007
Last verified: September 2007

April 24, 2007
November 13, 2007
September 2004
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  • forced expiratory volume in 1 second (FEV1)
  • forced expiratory flow rate (FEF25-75%)
Same as current
Complete list of historical versions of study NCT00465413 on ClinicalTrials.gov Archive Site
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Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler
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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.

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%).

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Device: Small volume spacer and/or Rinsing the mouth with water
Not Provided
Liu CL, Lu YT. Bronchodilatation effects of a small volume spacer used with a metered-dose inhaler. J Asthma. 2009 Sep;46(7):637-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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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.
Both
6 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00465413
MMH-I-S-317
Yes
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Mackay Memorial Hospital
Not Provided
Study Chair: Ching-Lung Liu, MD Mackay Memorial Taitung Branch Hospital
Principal Investigator: Yen-Ta Lu, MD, PhD. Mackay Memorial Tamshui Branch Hospital
Mackay Memorial Hospital
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP