An interventional study of Education on Use of MDI in Asthma and Chronic Obstructive Pulmonary Disease, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Health services research
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 23 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
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Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
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.
Other: Education on Use of MDI
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.
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: 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.
Time frame: Single event- Outcome measured per inhaler puff, during the single clinic visit.
| Milestone | MDI Use Evaluation |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
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.
| correct steps | MDI Use Evaluation |
|---|---|
| Inhaler Use Correctness | 3.52 ± 1.25 |
Collected over 1 day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Study I | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
23 physician-diagnosed Asthma/COPD patients were recruited for the study.
| Age, Continuous(years) | MDI Use Evaluation |
|---|---|
| Mean | 39.65 ± 13.93 |
| Sex: Female, Male(Participants) | MDI Use Evaluation |
|---|---|
| Female | 17 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | MDI Use Evaluation |
|---|
| Region of Enrollment(participants) | MDI Use Evaluation |
|---|---|
| United States | 23 |
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