- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307970
Impact of Anti-static Chamber/Mask
September 16, 2011 updated by: University of Florida
The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.
Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure.
Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily.
The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days.
A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%.
FP plasma concentrations were measured by liquid chromatography mass spectrometry assay.
Results evaluated using regression analysis.
Study Type
Interventional
Enrollment
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610-0486
- University of Florida Asthma Research Lab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively
Exclusion Criteria:
- inadequately controlled asthma: nocturnal awakening > 2 nights/month, prn albuterol use > 2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
one-hour steady-state plasma concentration of fluticasone after each device
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
March 24, 2006
First Submitted That Met QC Criteria
March 24, 2006
First Posted (Estimate)
March 28, 2006
Study Record Updates
Last Update Posted (Estimate)
September 20, 2011
Last Update Submitted That Met QC Criteria
September 16, 2011
Last Verified
June 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 582-2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on HFA FP MDI
-
University of FloridaGlaxoSmithKlineCompleted
-
AstraZenecaRecruitingMucociliary ClearanceUnited States
-
AstraZenecaCompleted
-
Boehringer IngelheimCompleted
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD)United States, Canada, Germany, Argentina, Bulgaria, Poland, Turkey, Mexico, United Kingdom
-
SunovionCompleted
-
AstraZenecaParexelCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
AstraZenecaNot yet recruitingChronic Obstructive Pulmonary DiseaseGermany, United Kingdom
-
AstraZenecaRecruiting