Trial Outcomes & Findings for Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use (NCT NCT01714063)

Last Updated: 2019-04-24

Results Overview

This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.

Recruitment status

COMPLETED

Target enrollment

34 participants

Primary outcome timeframe

Day 1

Results posted on

2019-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Pressurized Metered-Dose Inhaler All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered.
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pressurized Metered-Dose Inhaler All participants that were consented to use the Pressurized Metered-Dose Inhaler in this study were considered.
Overall Study Equipment malfunction	2

Baseline Characteristics

Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=32 Participants All participants that were consented to the study were considered.
Age, Continuous	6.4 years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants
Height	119.3 centimeters STANDARD_DEVIATION 7.7 • n=5 Participants
Weight	26.4 kilograms STANDARD_DEVIATION 8.6 • n=5 Participants
Time Using Valved Holding Chamber	3 years STANDARD_DEVIATION 2.5 • n=5 Participants
Previous Mouthpiece Experience	13 percentage of participants STANDARD_DEVIATION 41 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Age 5-6.5 n=16 Participants Group 1 will consist of 16 children aged 5-6.5 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler	Aged 6.6- 8 Years n=16 Participants Group 2 will consist of 16 children aged 6.6- 8 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler
Delivered Dose of Fluticasone (on the Filter) Coordinated	48 Percent filter dose of fluticasone Interval 44.0 to 52.0	45 Percent filter dose of fluticasone Interval 39.0 to 51.0
Delivered Dose of Fluticasone (on the Filter) Uncoordinated	41 Percent filter dose of fluticasone Interval 36.0 to 47.0	40 Percent filter dose of fluticasone Interval 35.0 to 45.0

PRIMARY outcome

Timeframe: Day 1

Population: 1 participant was excluded from the filter data because they were an outlier

Outcome measures

Outcome measures
Measure	Age 5-6.5 n=31 Participants Group 1 will consist of 16 children aged 5-6.5 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler	Aged 6.6- 8 Years Group 2 will consist of 16 children aged 6.6- 8 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler
Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers Coordinated	46 Percent filter dose of fluticasone Interval 43.0 to 50.0	—
Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers Uncoordinated	41 Percent filter dose of fluticasone Interval 37.0 to 44.0	—

SECONDARY outcome

Timeframe: Day 1

Population: 1. participant was excluded from both the coordinated because of their breathing profile 2. participants were excluded from the uncoordinated effort because of their breathing profile

Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air. This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers.

Outcome measures

Outcome measures
Measure	Age 5-6.5 n=31 Participants Group 1 will consist of 16 children aged 5-6.5 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler	Aged 6.6- 8 Years n=30 Participants Group 2 will consist of 16 children aged 6.6- 8 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler
Inspiratory Peak Flow 1st Breath	25.2 L/min Interval 20.5 to 30.0	22.8 L/min Interval 17.6 to 28.1
Inspiratory Peak Flow 2nd Breath	23.3 L/min Interval 18.5 to 28.1	22 L/min Interval 17.3 to 26.6
Inspiratory Peak Flow 3rd Breath	23.2 L/min Interval 18.3 to 28.0	22.5 L/min Interval 17.1 to 27.9
Inspiratory Peak Flow All Breaths	23.9 L/min Interval 21.3 to 26.5	22.4 L/min Interval 19.6 to 25.2

SECONDARY outcome

Timeframe: Day 1

Population: 1. participant was excluded from both the coordinated because of their breathing profile 2. participants were excluded from the uncoordinated effort because of their breathing profile

Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass. This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers.

Outcome measures

Outcome measures
Measure	Age 5-6.5 n=31 Participants Group 1 will consist of 16 children aged 5-6.5 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler	Aged 6.6- 8 Years n=30 Participants Group 2 will consist of 16 children aged 6.6- 8 years Pressurized Metered-Dose Inhaler: Pressurized Metered-Dose Inhaler
Inspiratory Tidal Volume 1st Breath	286 mL Interval 209.0 to 363.0	269 mL Interval 212.0 to 362.0
Inspiratory Tidal Volume 2nd Breath	281 mL Interval 215.0 to 363.0	259 mL Interval 186.0 to 333.0
Inspiratory Tidal Volume 3rd Breath	302 mL Interval 227.0 to 378.0	266 mL Interval 201.0 to 331.0
Inspiratory Tidal Volume All	291 mL Interval 250.0 to 332.0	271 mL Interval 228.0 to 314.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1

Population: This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study.

Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot

Outcome measures

Outcome data not reported

Adverse Events

All Study Participants

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

Ariel Perlinkski MT

Department of Pediatrics UAMS/COM

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place