Back to resultsMonitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Primary Purpose
Asthma, Copd
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respimetrix
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years of age or older
- Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
- Patients must be willing and able to provide informed consent to participate in the the study.
- Patients must be able to use a metered dose inhaler
Exclusion Criteria:
- Contraindication to inhaler use
- Tracheostomy
- Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
- Unable to understand informed consent (e.g. non-English speakers)
Sites / Locations
- Pulmonary and Critical Care Associates Of Baltimor
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MDI Training
Arm Description
All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design.
Outcomes
Primary Outcome Measures
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device
Measure actuation timing, flow rate and volume after intervention
Secondary Outcome Measures
Describing baseline pressurized metered-dose inhaler (pMDI) technique
Measure actuation timing, flow rate and volume before intervention.
Full Information
NCT ID
NCT05495256
First Posted
April 19, 2022
Last Updated
April 26, 2023
Sponsor
Pulmonary Critical Care Associates of Baltimore
Collaborators
Gerresheimer
1. Study Identification
Unique Protocol Identification Number
NCT05495256
Brief Title
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Official Title
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pulmonary Critical Care Associates of Baltimore
Collaborators
Gerresheimer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.
Detailed Description
Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.
This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Copd
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients are screened, consented, and all go through the inhaler training.
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDI Training
Arm Type
Other
Arm Description
All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design.
Intervention Type
Device
Intervention Name(s)
Respimetrix
Intervention Description
The Respimetrix device has a low resistance airflow sensor with an inhaler to measure patients inspiratory airflow and volume. This device will thereby provide quantifiable measures of lung function and bronchodilator delivery.
Primary Outcome Measure Information:
Title
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device
Description
Measure actuation timing, flow rate and volume after intervention
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Describing baseline pressurized metered-dose inhaler (pMDI) technique
Description
Measure actuation timing, flow rate and volume before intervention.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years of age or older
Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
Patients must be willing and able to provide informed consent to participate in the the study.
Patients must be able to use a metered dose inhaler
Exclusion Criteria:
Contraindication to inhaler use
Tracheostomy
Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
Unable to understand informed consent (e.g. non-English speakers)
Facility Information:
Facility Name
Pulmonary and Critical Care Associates Of Baltimor
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
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