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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465413
First Posted: April 25, 2007
Last Update Posted: November 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mackay Memorial Hospital
  Purpose
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.

Condition Intervention Phase
Asthma Device: Small volume spacer and/or Rinsing the mouth with water Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • forced expiratory volume in 1 second (FEV1)
  • forced expiratory flow rate (FEF25-75%)

Estimated Enrollment: 300
Study Start Date: September 2004
Detailed Description:

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%).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465413


Locations
Taiwan
Mackay Memorial Tamshui Branch Hospital
Tamshui, Taipei, Taiwan, 25115
Mackay Memorial Taitung Branch Hospital
Taitung, Taiwan, 95017
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Study Chair: Ching-Lung Liu, MD Mackay Memorial Taitung Branch Hospital
Principal Investigator: Yen-Ta Lu, MD, PhD. Mackay Memorial Tamshui Branch Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00465413     History of Changes
Other Study ID Numbers: MMH-I-S-317
First Submitted: April 24, 2007
First Posted: April 25, 2007
Last Update Posted: November 14, 2007
Last Verified: September 2007

Keywords provided by Mackay Memorial Hospital:
metered-dose inhalers (MDI)
forced expiratory volume in 1 second (FEV1)
forced expiratory flow rate (FEF25-75%)


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