Trial Outcomes & Findings for Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT02447575)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

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

Results posted on

2020-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	MDI Use Evaluation Patients perform metered dose inhaler (MDI) technique, attaching the Cognita electronic flowmeter to show measurements during the MDI use. These are evaluated by study staff prior to an education demonstration. The intervention is a short educational presentation on the correct use of the MDI. MDI use Evaluation: Subject will demonstrate the use of MDI) with an electronic flowmeter in place before a short education process to demonstrate current use of MDI
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MDI Use Evaluation n=23 Participants This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use.
Age, Continuous	39.65 years STANDARD_DEVIATION 13.93 • n=23 Participants
Sex: Female, Male Female	17 Participants n=23 Participants
Sex: Female, Male Male	6 Participants n=23 Participants
Region of Enrollment United States	23 participants n=23 Participants

PRIMARY outcome

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

Population: 23 subjects completed the study. Partial results were published in: 1\. Biswas, Rajoshi et al., Journal of aerosol medicine and pulmonary drug delivery 30.4 (2017): 256-266. Complete results were published in: 1\. Biswas, Rajoshi, et al., Chest Journal 150.4\_S (2016).

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.

Outcome measures

Outcome measures
Measure	MDI Use Evaluation n=23 Participants This was a single-arm study. All participants were instructed to use the MDI with the flow meter to gauge the correctness of use.
Inhaler Use Correctness	3.52 correct steps Standard Deviation 1.25

Adverse Events

Single Arm Study I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicola Hanania

Baylor College of Medicine

Phone: (713) 873-3454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place