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

Completed

• Conditions: Asthma
• Interventions: Device: Pressurized Metered-Dose Inhaler

• Registration Number: NCT01714063
• Lead Sponsor: Philips Respironics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Study Start: 2012-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2019-01-09
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Results First Posted: 2019-04-24
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aged 6.6- 8 years	Pressurized Metered-Dose Inhaler	Group 2 will consist of 16 children aged 6.6- 8 years
Age 5-6.5	Pressurized Metered-Dose Inhaler	Group 1 will consist of 16 children aged 5-6.5 years

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States