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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anti-static then static
Static then anti-static chamber
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Anti-static then Static for Albuterol

Static then Anti-static for Albuterol

Arm Description

albuterol anti-static first then static chamber second.

static then antistatic albuterol

Outcomes

Primary Outcome Measures

Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
(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
Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
(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
Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
(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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2010
Last Updated
February 3, 2022
Sponsor
University of Florida
Collaborators
Children's Miracle Network
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1. Study Identification

Unique Protocol Identification Number
NCT01111110
Brief Title
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Official Title
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Children's Miracle Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-static then Static for Albuterol
Arm Type
Experimental
Arm Description
albuterol anti-static first then static chamber second.
Arm Title
Static then Anti-static for Albuterol
Arm Type
Experimental
Arm Description
static then antistatic albuterol
Intervention Type
Device
Intervention Name(s)
anti-static then static
Intervention Description
Albuterol using static chambers
Intervention Type
Device
Intervention Name(s)
Static then anti-static chamber
Intervention Description
albuterol with Static then anti-static chambers
Primary Outcome Measure Information:
Title
Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description
(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
Time Frame
fifteen minutes after 1 puff of albuterol
Title
Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description
(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
Time Frame
15 minutes after 2 puffs of albuterol
Title
Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Description
(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
Time Frame
fifteen minutes after 4 puffs of albuterol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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

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