AsthmaNCT02447575
Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Education on Use of MDI in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary disease. It is well-known that most patients do not use correct technique when using a metered dose inhaler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Education on Use of MDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a physician diagnosis of asthma or COPD taking inhaled medications using MDI
- Age >18 years
- Able to read and sign consent document
Who cannot join
- Patients having acute exacerbation
- Patients who are unable to take medication from an MDI
Trial locations and contacts
1 site in 1 country.
About this study
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary disease. It is well-known that most patients do not use correct technique when using a metered dose inhaler. This leads to poor control of their disease. This study is being done so the investigators can record the patient using the metered dose inhaler before and after a short teaching session. This information will be fed into an invitro system (device) to allow the researchers to study the effect of error on drug delivery. The device being used is the Rice R3 electronic flowmeter.
Read the detailed description
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common platforms to deliver medicine for patients suffering from Asthma and chronic obstructive pulmonary disease, and are used for dispensing both controller and rescue medications. Despite well-known methods to manage Asthma and COPD, nearly 70-90% of the patients do not display correct technique in using an inhaler. Poor management and control of the disease due to inadequate inhaler usage has resulted in rising rates of hospitalizations, making chronic respiratory diseases among the top five causes of death worldwide. Through this study we aim to record the technique of MDI usage among Asthma and COPD patient and understand the errors in their technique. The various parameters of inhaler usage where patients can make an error are 1. Tidal volume, 2. inspiration flow rate, 3. Inspiration flow volume, 4. Timing of actuation of inhaler and 5. Breath-holding. The parameters will be recorded by the Cognita R3 electronic flowmeter for each patient and the errors in each MDI usage will be noted. Using ex-vivo modelling, the patient's MDI technique recorded will be used to study the impact of errors in technique on efficiency of MDI drug delivery.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Education on Use of MDI
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on Use of MDIOther
After the subject demonstrated the use of MDI with the electronic flowmeter in place, the intervention was provided- a short verbal education to demonstrate the correct use of MDI.
| Study group | Role | What they receive |
|---|---|---|
| MDI use Evaluation | Other | All subjects took 2 or more puffs of the placebo metered dose inhaler (MDI), attaching the Cognita electronic flowmeter to show measurements during the MDI use.
The inhaler technique is also evaluated by study staff prior to an education demonstration. Receives: Other: Education on Use of MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler Use Correctness
This is an observational study, the aim is to record a variety of MDI usage techniques performed by patients. The technique is scored out of 7 for the following 7 steps:
- Shaking (0 = not shaken, 1 = shaken)
- Coordination (0 = MDI actuated before inhalation start, 1 = MDI actuated after inhalation start)
- Flow rate (0 = mean inspiratory flow rate <30L/min or greater than 60L/min, 1 = mean inspiratory flow rate between 30-60L/min)
- Duration of inhalation (0 = duration of inhalation <3 sec, 1 = duration of inhalation >=3sec)
- Orientation of inhaler (0 = inhaler not upright = > 30° from the vertical position, 1 = inhaler upright = within 30° from the vertical position)
- Number of exhalation (0 = exhalation during inhaler use, 1 = no exhalations)
- Single Actuation (0 = less than 0 or more than 1 inhaler actuation, 1 = exactly 1 inhaler actuation)
The total score is a minimum of 0 correct steps if all the steps are incorrect to a maximum of 7 correct steps.
Measured: Single event- Outcome measured per inhaler puff, during the single clinic visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University
- Responsible party
- Principal investigator, Nicola Hanania, Baylor College of Medicine
- Investigators
- Nicola A Hanania, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447575
- Sponsor's protocol ID
- H36079
- Status last verified
- Sep 2020
- First submitted
- 12 May 2015
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Biswas R, Hanania NA, Sabharwal A. Factors Determining In Vitro Lung Deposition of Albuterol Aerosol Delivered by Ventolin Metered-Dose Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Aug;30(4):256-266. doi: 10.1089/jamp.2015.1278. Epub 2017 Feb 3.
PubMed 28157430
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT02447575
- Acronym / sponsor ID
- H36079
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- William Marsh Rice University
- Study start
- Feb 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common devices used to deliver medicine in conditions such as asthma and chronic obstructive pulmonary disease. It is well-known that most patients do not use correct technique when using a metered dose inhaler. This leads to poor control of their disease. This study is being done so the investigators can record the patient using the metered dose inhaler before and after a short teaching session. This information will be fed into an invitro system (device) to allow the researchers to study the effect of error on drug delivery. The device being used is the Rice R3 electronic flowmeter.
Detailed description
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common platforms to deliver medicine for patients suffering from Asthma and chronic obstructive pulmonary disease, and are used for dispensing both controller and rescue medications. Despite well-known methods to manage Asthma and COPD, nearly 70-90% of the patients do not display correct technique in using an inhaler. Poor management and control of the disease due to inadequate inhaler usage has resulted in rising rates of hospitalizations, making chronic respiratory diseases among the top five causes of death worldwide. Through this study we aim to record the technique of MDI usage among Asthma and COPD patient and understand the errors in their technique. The various parameters of inhaler usage where patients can make an error are 1. Tidal volume, 2. inspiration flow rate, 3. Inspiration flow volume, 4. Timing of actuation of inhaler and 5. Breath-holding. The parameters will be recorded by the Cognita R3 electronic flowmeter for each patient and the errors in each MDI usage will be noted. Using ex-vivo modelling, the patient's MDI technique recorded will be used to study the impact of errors in technique on efficiency of MDI drug delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDI use Evaluation | Other | Other: Education on Use of MDIAll subjects took 2 or more puffs of the placebo metered dose inhaler (MDI), attaching the Cognita electronic flowmeter to show measurements during the MDI use. The inhaler technique is also evaluated by study staff prior to an education demonstration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a physician diagnosis of asthma or COPD taking inhaled medications using MDI
- Age >18 years
- Able to read and sign consent document
Key exclusion criteria (2 listed)
- Patients having acute exacerbation
- Patients who are unable to take medication from an MDI
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 |
|---|---|---|
| Education on Use of MDIAfter the subject demonstrated the use of MDI with the electronic flowmeter in place, the intervention was provided- a short verbal education to demonstrate the correct use of MDI. | Other | MDI use Evaluation |
Primary outcome
Inhaler Use Correctness
Time frame: Single event- Outcome measured per inhaler puff, during the single clinic visit.
This is an observational study, the aim is to record a variety of MDI usage techniques performed by patients. The technique is scored out of 7 for the following 7 steps: 1. Shaking (0 = not shaken, 1 = shaken) 2. Coordination (0 = MDI actuated before inhalation start, 1 = MDI actuated after inhalation start) 3. Flow rate (0 = mean inspiratory flow rate <30L/min or greater than 60L/min, 1 = mean inspiratory flow rate between 30-60L/min) 4. Duration of inhalation (0 = duration of inhalation <3 sec, 1 = duration of inhalation >=3sec) 5. Orientation of inhaler (0 = inhaler not upright = > 30° from the vertical position, 1 = inhaler upright = within 30° from the vertical position) 6. Number of exhalation (0 = exhalation during inhaler use, 1 = no exhalations) 7. Single Actuation (0 = less than 0 or more than 1 inhaler actuation, 1 = exactly 1 inhaler actuation) The total score is a minimum of 0 correct steps if all the steps are incorrect to a maximum of 7 correct steps.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28157430Biswas R, Hanania NA, Sabharwal A. Factors Determining In Vitro Lung Deposition of Albuterol Aerosol Delivered by Ventolin Metered-Dose Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Aug;30(4):256-266. doi: 10.1089/jamp.2015.1278. Epub 2017 Feb 3.
- Individual participant dataSharing planned: No
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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.
Nicola A Hanania, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on Use of MDI in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Baylor College of Medicine at 1 site in United States.
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 3 inclusion and 2 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inhaler Use Correctness (time frame: Single event- Outcome measured per inhaler puff, during the single clinic visit.). 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 NCT02447575, 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 9 Oct 2020.