Asthma, Chronic Obstructive Pulmonary Disease
Conditions
Brief 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. 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.
Interventions
OTHEREducation 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.
Sponsors
William Marsh Rice University
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a physician diagnosis of asthma or COPD taking inhaled medications using MDI * Age \>18 years * Able to read and sign consent document
Exclusion criteria
* Patients having acute exacerbation * Patients who are unable to take medication from an MDI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhaler Use Correctness | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MDI Use Evaluation This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | MDI Use Evaluation | — |
|---|---|---|
| Age, Continuous | 39.65 years STANDARD_DEVIATION 13.93 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 23 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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.
Population: 23 subjects completed the study.~Partial results were published in:~1\. Biswas, Rajoshi et al., Journal of aerosol medicine and pulmonary drug delivery 30.4 (2017): 256-266.~Complete results were published in:~1\. Biswas, Rajoshi, et al., Chest Journal 150.4\_S (2016).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDI Use Evaluation | Inhaler Use Correctness | 3.52 correct steps | Standard Deviation 1.25 |