Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase: NA
Conditions: Asthma, Chronic Obstructive Pulmonary Disease
Sponsor: Baylor College of Medicine

 
 
DETECTING ERRORS IN USING METERED DOSE INHALERS 
(MDI) AMONG ASTHMA AND COPD PATIENTS 
NCT02447575 
Date: 09/09/2020 

Section C: Background 
Obstructive lung disease is associated with significant morbidity and mortality worldwide [1]. Asthma and 
chronic obstructive pulmonary disease (COPD) comprise two of the largest groups of obstructive lung 
disease [1], impacting nearly 510 million globally [5]. About 255,000 people die from asthma each year 
[2], and 80% of these deaths occur in low and middle--income countries [3]. Asthma continues to be the 
most common chronic disease among children [4]. COPD is expected to become the third leading cause 
of death worldwide by 2030 [2]. 
The treatment for Asthma and COPD patients consists of a combination of controller and rescue 
medications. The control (maintenance) medication is taken daily (once or more, based on prescription) 
to keep the disease symptoms in control and avoid reaction towards triggers that cause exacerbations 
(asthma attacks). The rescue (also sometimes referred as emergency) medication is used during an 
exacerbation. The rescue medication provides temporary relief and has higher efficacy if the patient is 
compliant with the daily control medication regime.There is a strong clinical evidence that regular use of 
the controller medication minimizes long--term damage to the lungs, and results in improved health 
outcomes for the patients [6, 7, 15]. Additionally, regular, effective dosing of asthma inhaler medication 
leads to well controlled asthma, reflected as low incidences of asthma--related exacerbations, 
hospitalizations and deaths. 
Metered Dose Inhaler (MDI) and Dry Powdered Inhaler (DPI) are the two most common platforms to 
deliver medicine for patients suffering from Asthma and COPD, 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 [8--14, 15]. 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, 
inspiration flow rate, 3. Inspiration flow volume, 4. Timing of actuation of inhaler and 5. Breadth holding. 
The parameters will be recorded 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. 
Section D: Purpose and Objectives 
The purpose of this research is to quantify the impact of errors in MDI usage technique on the lung 
deposition of the medication. In order to achieve the above goal, we will conduct the current study to 
electronically measure the MDI usage technique by patients, before and after coaching by a trained 
technician or Doctor, in a clinic environment. 
Section E: Protocol Risks/Subjects 
E1. Risk Category 
Category 1: Research not involving greater than minimum risk. 
E2. Subjects 
Gender: Both 

Age: Adult (18--64 yrs), Geriatric (65+ yrs) 
Ethnicity: All Ethnicities 
Primary Language: English, Spanish 
Groups to be recruited will include: Patients 
Vulnerable populations to be recruited as subjects: Vulnerable populations require special protections. 
How will you obtain informed consent, protect subject confidentiality, and prevent undue coercion? 
No vulnerable populations will be recruited 
E3. Pregnant woman/fetus 
Will pregnant women be enrolled in the research? 
No 
E4. Neonates 
Will neonates be enrolled in the research? 
No 
E5. Children 
Will children be enrolled in the research? 
No 
Section F: Design/Procedure 
F1. Design 
Select one category that most adequately describes your research: 
d) Questionnaire/survey/interview 
Discuss the research design including but not limited to such issues as: probability of group assignment, 
potential for subject to be randomized to placebo group, use of control subjects, etc. 
This trial is an observational study aimed at capturing and understanding the errors made by Asthma and 
COPD patients in their technique of using an MDI. The patients will take a dose from a placebo MDI 
attached to an electronic flow meter to record their usage before and after receiving instructions on how 
to use the inhalers. The MDI usage data will be used for further in--vitro studies to understand efficacy of 
MDI and lung deposition. 
There is no randomization of subjects. We will be recording the patients use of a placebo inhaler attached 
to an electronic flowmeter. 
Inclusion Criteria: 
1. Patients with a physician diagnosis of asthma or COPD taking inhaled medications using MDI 

2. Age >18 years 
3. Able to read and sign consent document. 
Exclusion Criteria: 
1. Patients having acute exacerbation 
2. Patients who are unable to take medication from an MDI 
F2. Procedure 
The study will be offered to asthma and COPD patients arriving at the Harris Health Smith Pulmonary Clinic 
or at the PFT lab at Ben Taub Hospital. Potential subjects will be asked if they are interested and if they 
currently use MDIs to take their medicine. The subject will be given time to read and ask questions about 
the study. After obtaining signed consent, the technician or medical staff member will oversee and guide 
the subject through the study. 
The subject will be given a placebo MDI with an electronic attachment consisting of a flow meter, force 
sensor and microcontroller to record the inhaler usage parameters such as inspiration/expiration flow 
rates, flow volumes, MDI actuation and breadth hold. A checklist will be developed which clearly states 
all the steps for using an MDI. The checklist will be coded by a serial number for the patient such that the 
subject's name or other personal identifiers are not recorded. 
The subject will be asked to perform a sample MDI dosing using the placebo MDI attached to the 
electronic monitor described above. The patients will only inhale from the MDI--flowmeter setup. Each 
MDI--flowmeter setup has a separate disposable mouthpiece for each patient. The electronic monitor will 
send all the data collected during MDI dosage through Bluetooth to the study team's android phone or 
computer and store the information for each dosage in the coded format of the checklist (serial number). 
The staff will record the validity or errors in each step of MDI usage in the checklist.  
Next, the subject will be given a short education session on how to correctly use an MDI. The subject will 
perform another MDI dosage maneuver with the placebo MDI attached to the electronic monitor. The 
second dosage, after training by the staff, will be recorded and stored in the phone or computer. The staff 
will again record the validity or errors in each step of MDI usage in the checklist.  
Section G: Sample Size/Data Analysis 
G1. Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
Local: 120 Worldwide: 120 
Please indicate why you chose the sample size proposed: 
Since this is an observational study, the aim is to record a variety of MDI usage techniques performed by 
patients. We are recruiting patients from age 18 and above. We will be dividing the patient population 
into five age groups of: 18--32, 33--47, 48--62, 63--77, 78 and above. We expect to recruit at least 20 
patients from each group and hence, the number of subjects is at least 100. We have chosen 120 to 

account for the fact that some groups may have more patients and we may record more than 20 patients 
for those age groups. 
G2. Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. 
comparison of means, comparison of proportions, regressions, analysis of variance). Which is the 
PRIMARY comparison/analysis? How will the analyses proposed relate to the primary purposes of your 
study? 
First, we will extract and separate the information about inhalation flow rates, timing and MDI actuation 
from the raw patient data collected from this study. The post processed patient data will not undergo any 
inference or analysis. The data collected from each patient will serve as input to a 'In--Vitro Lung 
Deposition Experiment'. The patient data represents the MDI usage of a patient, and each patient data 
point collected in this study will be fed into the 'In--Vitro Lung Deposition Experiment' to understand lung 
deposition of medication for that patient. Thus, this study is only aimed at collecting the different types 
of MDI usages by Asthma and COPD patients. 
Section H: Potential Risks/Discomforts 
H1. Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts and assess the likelihood and seriousness of such 
risks: Participants will use placebo MDIs (inhalers without active medication) during the study. There is a 
very slight risk that the propellant in the placebo metered dose inhaler could cause bronchospasm. All 
subjects will be monitored for this occurrence and will be give a short--acting bronchodilator immediately 
if this occurs. 
A separate mouthpiece system will be used to make sure there is no contamination between patients. 
The participant may find some minor discomfort in using the MDI-- flowmeter setup since it is different 
than the normal MDI. The medical staff conducting the study will guide the participants to make the 
process easier. 
There is minimal risk of loss of confidentiality. The patient's name or birthdate will not be entered in the 
electronic recording. The subject number is coded as a serial number. We will record the gender, age, 
height and weight of each patient, as part of the testing information. No other personal, patient 
identifiable information will be collected. 
All subjects are free to end their participation in the study at any time they wish.  
H2. Data and safety monitoring plan 
Do the study activities impart greater than minimal risk to subjects? 
No 
H3. Coordination of information among sites for multi--site research 
Is the BCM Principal Investigator acting as the SPONSOR--INVESTIGATOR for this multi--site research? 
No or Not Applicable 

Is BCM the COORDINATING CENTER for this multi--site research? 
No or Not Applicable 
Section I: Potential Benefits 
Describe potential benefits to be gained by the individual subject as a result of participating in the planned 
work. 
The patient will receive additional training on the use of an MDI by the technician or medical staff. In turn, 
this can improve the subject's ability to take their medication properly. 
Describe potential benefits to society of the planned work. 
This study will help the study doctors and research team understand more about which steps in the proper 
use of the metered dose inhaler can impact treatment of patients with asthma or COPD. 
Do anticipated benefits outweigh potential risks? Discuss the risk--to--benefit ratio. 
The risk is minimal thus the anticipated benefits outweigh the potential risks. The risk to benefit ratio 
weighs on the side of benefit.