AsthmaNCT01714063
Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
An observational study of Asthma, run by Philips Respironics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pressurized Metered-Dose Inhaler
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: 40 subjects aged 5-8 diagnosed with asthma
Who may be able to join
- • 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Asthma
- Being tested
- Pressurized Metered-Dose Inhaler
- Keywords
- pediatric, asthma, metered dose inhaler, valved holding chamber, pMDI, VHC
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressurized Metered-Dose InhalerDevice
Pressurized Metered-Dose Inhaler
| Study group | Role | What they receive |
|---|---|---|
| Age 5-6.5 | Group 1 will consist of 16 children aged 5-6.5 years Receives: Device: Pressurized Metered-Dose Inhaler | |
| Aged 6.6- 8 years | Group 2 will consist of 16 children aged 6.6- 8 years Receives: Device: Pressurized Metered-Dose Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariel Berlinski, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714063
- Sponsor's protocol ID
- RDD-2010-001
- Status last verified
- Apr 2019
- First submitted
- 18 Oct 2012
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29162718Berlinski 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.
PubMed 27977309
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01714063
- Acronym / sponsor ID
- RDD-2010-001
- Conditions
- Asthma
- Keywords
- pediatric, asthma, metered dose inhaler, valved holding chamber, pMDI, VHC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Posted 24 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 5-6.5 | – | Device: Pressurized Metered-Dose InhalerGroup 1 will consist of 16 children aged 5-6.5 years |
| Aged 6.6- 8 years | – | Device: Pressurized Metered-Dose InhalerGroup 2 will consist of 16 children aged 6.6- 8 years |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 40 subjects aged 5-8 diagnosed with asthma
Key inclusion criteria (9 listed)
- • Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's Hospital.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressurized Metered-Dose InhalerPressurized Metered-Dose Inhaler | Device | Age 5-6.5, Aged 6.6- 8 years |
Primary outcome
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.
2 secondary outcomes
Inspiratory Peak Flow
Time frame: Day 1
Inspiratory Tidal Volume
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29162718Berlinski 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.
- Derived from this study: PubMed 27977309Berlinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Berlinski, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivered Dose of Fluticasone (on the Filter) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714063, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.