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

NCT ID: NCT00465413

Last Updated: 2007-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Small volume spacer and/or Rinsing the mouth with water

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mackay Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ching-Lung Liu, MD

Role: STUDY_CHAIR

Mackay Memorial Taitung Branch Hospital

Yen-Ta Lu, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Tamshui Branch Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mackay Memorial Tamshui Branch Hospital

Tamshui, Taipei, Taiwan

Site Status

Mackay Memorial Taitung Branch Hospital

Taitung, Taitung, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Liu CL, Lu YT. Bronchodilatation effects of a small volume spacer used with a metered-dose inhaler. J Asthma. 2009 Sep;46(7):637-41. doi: 10.1080/02770900802492111.

Reference Type DERIVED
PMID: 19728196 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mmh.org.tw/

Home page of Mackay Memorial Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMH-I-S-317

Identifier Type: -

Identifier Source: org_study_id