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Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education on Use of MDI
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MDI use Evaluation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2015
Last Updated
September 12, 2020
Sponsor
Baylor College of Medicine
Collaborators
William Marsh Rice University
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1. Study Identification

Unique Protocol Identification Number
NCT02447575
Brief Title
Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
William Marsh Rice University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDI use Evaluation
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education on Use of MDI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inhaler Use Correctness
Description
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.
Time Frame
Single event- Outcome measured per inhaler puff, during the single clinic visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola A Hanania, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28157430
Citation
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.
Results Reference
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Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients

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