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

NCT02447575 | Completed Results

• 1 other identifier: H36079
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Single event- Outcome measured per inhaler puff, during the single clinic visit.

Study Arms (1)

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.

Other: Education on Use of MDI

Interventions

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.

MDI use Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a physician diagnosis of asthma or COPD taking inhaled medications using MDI
• Age \>18 years
• Able to read and sign consent document

You may not qualify if:

• Patients having acute exacerbation
• Patients who are unable to take medication from an MDI

Sponsors & Collaborators

• Baylor College of Medicine: lead
• William Marsh Rice University: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28157430 RESULT

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Nicola Hanania
• Organization: Baylor College of Medicine

hanania@bcm.edu

(713) 873-3454

Study Officials

• Nicola A Hanania, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 19, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)