Asthma
Conditions
Keywords
pediatric, asthma, metered dose inhaler, valved holding chamber, pMDI, VHC
Brief summary
The primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.
Interventions
DEVICEPressurized Metered-Dose Inhaler
Pressurized Metered-Dose Inhaler
Sponsors
Philips Respironics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* • Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's Hospital. * The subjects must be available to complete the study. * The subject's parent(s) and/or the subject's legal guardian must provide written informed consent to participate in the study. * The subject must provide assent when older than 7 years old. * The subjects should have used a pMDI VHC previously and be able to use a VHC with mouthpiece. * The subjects should have been prescribed fluticasone or another inhaled corticosteroid delivered via a pMDI VHC combination. * Clinically stable asthma. * Cooperative, i.e., subject should be able to follow and understand instructions. * The subject must satisfy the study investigator about his/her fitness to participate in the study.
Exclusion criteria
* Clinically significant respiratory disease in the previous 4 weeks. * Participation in any other clinical trial in the previous 4 weeks. * Lack of cooperation, subject cannot follow and understand instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivered Dose of Fluticasone (on the Filter) | Day 1 | 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. |
| Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Peak Flow | Day 1 | 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. |
| Inspiratory Tidal Volume | Day 1 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC | Day 1 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants that were consented to the study were considered. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment malfunction | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 6.4 years STANDARD_DEVIATION 0.8 |
| Height | 119.3 centimeters STANDARD_DEVIATION 7.7 |
| Previous Mouthpiece Experience | 13 percentage of participants STANDARD_DEVIATION 41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 20 Participants |
| Time Using Valved Holding Chamber | 3 years STANDARD_DEVIATION 2.5 |
| Weight | 26.4 kilograms STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Delivered Dose of Fluticasone (on the Filter)
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.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Age 5-6.5 | Delivered Dose of Fluticasone (on the Filter) | Uncoordinated | 41 Percent filter dose of fluticasone |
| Age 5-6.5 | Delivered Dose of Fluticasone (on the Filter) | Coordinated | 48 Percent filter dose of fluticasone |
| Aged 6.6- 8 Years | Delivered Dose of Fluticasone (on the Filter) | Coordinated | 45 Percent filter dose of fluticasone |
| Aged 6.6- 8 Years | Delivered Dose of Fluticasone (on the Filter) | Uncoordinated | 40 Percent filter dose of fluticasone |
p-value: <0.001paired t-test
Primary
Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
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.
Time frame: Day 1
Population: 1 participant was excluded from the filter data because they were an outlier
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Age 5-6.5 | Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers | Coordinated | 46 Percent filter dose of fluticasone |
| Age 5-6.5 | Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers | Uncoordinated | 41 Percent filter dose of fluticasone |
Secondary
Inspiratory Peak Flow
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Age 5-6.5 | Inspiratory Peak Flow | 2nd Breath | 23.3 L/min |
| Age 5-6.5 | Inspiratory Peak Flow | 1st Breath | 25.2 L/min |
| Age 5-6.5 | Inspiratory Peak Flow | 3rd Breath | 23.2 L/min |
| Age 5-6.5 | Inspiratory Peak Flow | All Breaths | 23.9 L/min |
| Aged 6.6- 8 Years | Inspiratory Peak Flow | All Breaths | 22.4 L/min |
| Aged 6.6- 8 Years | Inspiratory Peak Flow | 2nd Breath | 22 L/min |
| Aged 6.6- 8 Years | Inspiratory Peak Flow | 3rd Breath | 22.5 L/min |
| Aged 6.6- 8 Years | Inspiratory Peak Flow | 1st Breath | 22.8 L/min |
Secondary
Inspiratory Tidal Volume
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Age 5-6.5 | Inspiratory Tidal Volume | 2nd Breath | 281 mL |
| Age 5-6.5 | Inspiratory Tidal Volume | 1st Breath | 286 mL |
| Age 5-6.5 | Inspiratory Tidal Volume | 3rd Breath | 302 mL |
| Age 5-6.5 | Inspiratory Tidal Volume | All | 291 mL |
| Aged 6.6- 8 Years | Inspiratory Tidal Volume | All | 271 mL |
| Aged 6.6- 8 Years | Inspiratory Tidal Volume | 1st Breath | 269 mL |
| Aged 6.6- 8 Years | Inspiratory Tidal Volume | 2nd Breath | 259 mL |
| Aged 6.6- 8 Years | Inspiratory Tidal Volume | 3rd Breath | 266 mL |
Other Pre-specified
Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC
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
Time frame: 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.