AsthmaPhase 2MDINCT00465413
Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler
A Phase 2 study testing Small volume spacer and/or Rinsing the mouth with water in people with Asthma, run by Mackay Memorial Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Small volume spacer and/or Rinsing the mouth with water
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesTaiwan
- Study dates
- Sep 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- age > 6 years old,
- subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry.
Who cannot join
- refusal to participate,
- negative bronchodilator test,
- poor performance of pulmonary function testing.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Mackay Memorial Taitung Branch Hospital
Taitung, Taitung, 95017
Mackay Memorial Tamshui Branch Hospital
Tamshui, Taipei, 25115
About this study
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.
Read the 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%).
- Conditions
- Asthma
- Being tested
- Small volume spacer and/or Rinsing the mouth with water
- Keywords
- metered-dose inhalers (MDI), forced expiratory volume in 1 second (FEV1), forced expiratory flow rate (FEF25-75%)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small volume spacer and/or Rinsing the mouth with waterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume in 1 second (FEV1)
forced expiratory flow rate (FEF25-75%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ching-Lung Liu, MD, Study chair, Mackay Memorial Taitung Branch HospitalYen-Ta Lu, MD, PhD., Principal investigator, Mackay Memorial Tamshui Branch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465413
- Sponsor's protocol ID
- MMH-I-S-317
- Acronym
- MDI
- Status last verified
- Sep 2007
- First submitted
- 24 Apr 2007
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19728196
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler
- ClinicalTrials.gov ID
- NCT00465413
- Acronym / sponsor ID
- MDI / MMH-I-S-317
- Conditions
- Asthma
- Keywords
- metered-dose inhalers (MDI), forced expiratory volume in 1 second (FEV1), forced expiratory flow rate (FEF25-75%)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age > 6 years old,
- subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry.
Key exclusion criteria (3 listed)
- refusal to participate,
- negative bronchodilator test,
- poor performance of pulmonary function testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small volume spacer and/or Rinsing the mouth with water | Device | – |
Primary outcome
forced expiratory volume in 1 second (FEV1)
forced expiratory flow rate (FEF25-75%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
- Derived from this study: PubMed 19728196Liu 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.
- Home page of Mackay Memorial HospitalLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Lung Liu, MD study chair
Mackay Memorial Taitung Branch Hospital
Yen-Ta Lu, MD, PhD. principal investigator
Mackay Memorial Tamshui Branch Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Small volume spacer and/or Rinsing the mouth with water in people with Asthma, run by Mackay Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced expiratory volume in 1 second (FEV1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00465413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.