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Completed

NCT Number: NCT01714063

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pressurized Metered-Dose Inhaler

Device

Pressurized Metered-Dose Inhaler

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2012
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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