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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Notify MeKey information
Conditions
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
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
Primary outcomes
-
forced expiratory volume in 1 second (FEV1)
-
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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