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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

April 23, 2010
May 14, 2012
May 2008
April 2009   (final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT01111110 on ClinicalTrials.gov Archive Site
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Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Device: anti-static then static
    Albuterol using static chambers
  • Device: Static then anti-static chamber
    albuterol with Static then anti-static chambers
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
March 2010
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01111110
IRB 103-2008, Children's Miracle Network UFl
No
University of Florida
University of Florida
Children's Miracle Network
Not Provided
University of Florida
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP