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

Resource links provided by NLM:


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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Mackay Memorial Hospital

Additional 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
Study First Received: April 24, 2007
Last Updated: November 13, 2007
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014