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| Name | Class |
|---|---|
| William Marsh Rice University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education on Use of MDI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The total score is a minimum of 0 correct steps if all the steps are incorrect to a maximum of 7 correct steps. | Single event- Outcome measured per inhaler puff, during the single clinic visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola A Hanania, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28157430 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MDI Use Evaluation | Patients perform metered dose inhaler (MDI) technique, attaching the Cognita electronic flowmeter to show measurements during the MDI use. These are evaluated by study staff prior to an education demonstration. The intervention is a short educational presentation on the correct use of the MDI. MDI use Evaluation: Subject will demonstrate the use of MDI) with an electronic flowmeter in place before a short education process to demonstrate current use of MDI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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23 physician-diagnosed Asthma/COPD patients were recruited for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
The total score is a minimum of 0 correct steps if all the steps are incorrect to a maximum of 7 correct steps. | 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). | Posted | Mean | Standard Deviation | correct steps | Single event- Outcome measured per inhaler puff, during the single clinic visit. |
1 day.
The study was a single inhaler use event with placebo medication. The risk of adverse events with less than 4 doses of placebo medication is low. The reporting is based on self-report by the participant on the day of the placebo MDI use. The event is reported if a participant faced and reported an adverse event post MDI use at the clinic/study visit on the day of the study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study I | This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nicola Hanania | Baylor College of Medicine | (713) 873-3454 | hanania@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2020 | Sep 10, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2020 | Sep 10, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |