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Completed

NCT Number: NCT01111110

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anti-static then static

Device

Albuterol using static chambers

Static then anti-static chamber

Device

albuterol with Static then anti-static chambers

Primary outcomes

  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 (Forced Expiratory Volume and Forced Vital Capacity) 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(Forced Expiratory Volume and Forced Vital Capacity) 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 (Forced Expiratory Volume and Forced Vital Capacity) 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Children's Miracle Network

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 27, 2010
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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