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

September 12, 2020 updated by: Nicola Hanania, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MDI use Evaluation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single event- Outcome measured per inhaler puff, during the single clinic visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

William Marsh Rice University

Investigators

  • Principal Investigator: Nicola A Hanania, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H36079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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