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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465413
Acronym
MDI
Enrollment
300
Registered
2007-04-25
Start date
2004-09-30
Completion date
Unknown
Last updated
2007-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

metered-dose inhalers (MDI), forced expiratory volume in 1 second (FEV1), forced expiratory flow rate (FEF25-75%)

Brief summary

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.

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%).

Interventions

DEVICESmall volume spacer and/or Rinsing the mouth with water

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frame
forced expiratory volume in 1 second (FEV1)
forced expiratory flow rate (FEF25-75%)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026