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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01111110
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Asthma Device: anti-static then static Device: Static then anti-static chamber

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Study Start Date : May 2008
Primary Completion Date : April 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Anti-static then Static for Albuterol
albuterol anti-static first then static chamber second.
Device: anti-static then static
Albuterol using static chambers
Experimental: Static then Anti-static for Albuterol
static then antistatic albuterol
Device: Static then anti-static chamber
albuterol with Static then anti-static chambers


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    (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

  2. 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 ]
    (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

  3. 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 ]
    (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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111110


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Children's Miracle Network
More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01111110     History of Changes
Other Study ID Numbers: IRB 103-2008
Children's Miracle Network UFl ( Other Grant/Funding Number: Children's Miracle Network, University of Florida )
First Posted: April 27, 2010    Key Record Dates
Results First Posted: June 19, 2012
Last Update Posted: June 19, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action