Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler (MDI)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- forced expiratory volume in 1 second (FEV1)
- forced expiratory flow rate (FEF25-75%)
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2004 |
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 |
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| Taiwan | |
| Mackay Memorial Tamshui Branch Hospital | |
| Tamshui, Taipei, Taiwan, 25115 | |
| Mackay Memorial Taitung Branch Hospital | |
| Taitung, Taiwan, 95017 | |
| 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 May 16, 2013