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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
History of Changes
  Purpose

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


Condition Intervention
Asthma
 Device: anti-static then static
Device: Static then anti-static chamber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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


Enrollment: 88
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01111110     History of Changes
Other Study ID Numbers: IRB 103-2008, Children's Miracle Network UFl
Study First Received: April 23, 2010
Results First Received: January 10, 2012
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013