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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714063
• Other study ID #: RDD-2010-001
• Status: Completed
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2019
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Pressurized Metered-Dose Inhaler
Pressurized Metered-Dose Inhaler

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1