Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

This study has been completed.

Sponsor:

Collaborator:

Children's Miracle Network

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT01111110

First received: April 23, 2010

Last updated: May 14, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 23, 2010
Last Updated Date	May 14, 2012
Start Date ^ICMJE	May 2008
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 14, 2012)	Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [ Time Frame: fifteen minutes after 1 puff of albuterol ] [ Designated as safety issue: No ] (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [ Time Frame: 15 minutes after 2 puffs of albuterol ] [ Designated as safety issue: No ] (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. [ Time Frame: fifteen minutes after 4 puffs of albuterol ] [ Designated as safety issue: No ] (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01111110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Official Title ^ICMJE	Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Brief Summary	Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Device: anti-static then static Albuterol using static chambers Device: Static then anti-static chamber albuterol with Static then anti-static chambers
Study Arm (s)	Experimental: Anti-static then Static for Albuterol albuterol anti-static first then static chamber second. Intervention: Device: anti-static then static Experimental: Static then Anti-static for Albuterol static then antistatic albuterol Intervention: Device: Static then anti-static chamber
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	88
Completion Date	March 2010
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18-65 years. Physician diagnosis of asthma. FEV1 60-80% predicted during the day. FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC. No smoking in the previous year and < 10-pack year history. No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months. Exclusion Criteria: Patient required a short course of oral steroid in the past 30 days. Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications. History of viral respiratory tract infection in the 3 weeks prior to the screening visit. Positive pregnancy test.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01111110
Other Study ID Numbers ^ICMJE	IRB 103-2008, Children's Miracle Network UFl
Has Data Monitoring Committee	No
Responsible Party	University of Florida
Study Sponsor ^ICMJE	University of Florida
Collaborators ^ICMJE	Children's Miracle Network
Investigators ^ICMJE	Not Provided
Information Provided By	University of Florida
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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