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NCT00465413 Clinical Trial

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

Asthma Clinical Trial

— MDI  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00465413
Other study ID # MMH-I-S-317
Secondary ID
Status Completed
Phase Phase 2
First received April 24, 2007
Last updated November 13, 2007
Start date September 2004

Study information
Verified date September 2007
Source Mackay Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 6 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Small volume spacer and/or Rinsing the mouth with water

Locations
Country Name City State
Taiwan Mackay Memorial Taitung Branch Hospital Taitung
Taiwan Mackay Memorial Tamshui Branch Hospital Tamshui Taipei

Sponsors (1)
Lead Sponsor Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary forced expiratory volume in 1 second (FEV1)
Primary forced expiratory flow rate (FEF25-75%)
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