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

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ClinicalTrials.gov Identifier: NCT01714063
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Tracking Information
First Submitted Date October 18, 2012
First Posted Date October 25, 2012
Results First Submitted Date January 9, 2019
Results First Posted Date April 24, 2019
Last Update Posted Date April 24, 2019
Study Start Date December 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
  • Delivered Dose of Fluticasone (on the Filter) [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 22, 2012)
Delivered dose of fluticasone (on the filter) [ Time Frame: Day 1 ]
The primary objective of the present study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond VHC mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2019)
  • Inspiratory Peak Flow [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: October 22, 2012)
  • Inspiratory peak flow [ Time Frame: Day 1 ]
    Correlate inspiratory peak flow and inspiratory tidal volume recorded during the inhalation with amount of drug (fluticasone) deposited on filters attached to the OptiChamber Diamond VHC mouthpiece
  • Inspiratory tidal volume [ Time Frame: Day 1 ]
    Correlate inspiratory peak flow and inspiratory tidal volume recorded during the inhalation with amount of drug (fluticasone) deposited on filters attached to the OptiChamber Diamond VHC mouthpiece
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2019)
Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC [ Time Frame: 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
Original Other Pre-specified Outcome Measures
 (submitted: October 22, 2012)
Measurement residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC [ Time Frame: 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 pMDI boot
 
Descriptive Information
Brief Title Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
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
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 40 subjects aged 5-8 diagnosed with asthma
Condition Asthma
Intervention Device: Pressurized Metered-Dose Inhaler
Pressurized Metered-Dose Inhaler
Study Groups/Cohorts
  • Age 5-6.5
    Group 1 will consist of 16 children aged 5-6.5 years
    Intervention: Device: Pressurized Metered-Dose Inhaler
  • Aged 6.6- 8 years
    Group 2 will consist of 16 children aged 6.6- 8 years
    Intervention: Device: Pressurized Metered-Dose Inhaler
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2019)
34
Original Estimated Enrollment
 (submitted: October 22, 2012)
40
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01714063
Other Study ID Numbers RDD-2010-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Philips Respironics
Original Responsible Party Same as current
Current Study Sponsor Philips Respironics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ariel Berlinski, MD University of Arkansas
PRS Account Philips Respironics
Verification Date April 2019