Clinical trial NCT01714063: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: pediatric
asthma
metered dose inhaler
valved holding chamber
pMDI
VHC
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 subjects aged 5-8 diagnosed with asthma

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.


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.

Primary outcomes:
measure: Delivered Dose of Fluticasone (on the Filter)
timeFrame: Day 1
measure: Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
timeFrame: Day 1
Secondary outcomes:
measure: Inspiratory Peak Flow
timeFrame: Day 1
measure: Inspiratory Tidal Volume
timeFrame: Day 1
Other outcomes:
measure: Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC
timeFrame: Day 1
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Ariel Berlinski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berlinski A, von Hollen D, Pritchard JN, Hatley RH. Delay Between Shaking and Actuation of a Hydrofluoroalkane Fluticasone Pressurized Metered-Dose Inhaler. Respir Care. 2018 Mar;63(3):289-293. doi: 10.4187/respcare.05782. Epub 2017 Nov 21.
citation: Berlinski A, von Hollen D, Hatley RHM, Hardaker LEA, Nikander K. Drug Delivery in Asthmatic Children Following Coordinated and Uncoordinated Inhalation Maneuvers: A Randomized Crossover Trial. J Aerosol Med Pulm Drug Deliv. 2017 Jun;30(3):182-189. doi: 10.1089/jamp.2016.1337. Epub 2016 Dec 15.