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

NCT ID: NCT01111110

Last Updated: 2022-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anti-static then Static for Albuterol

albuterol anti-static first then static chamber second.

Group Type EXPERIMENTAL

anti-static then static

Intervention Type DEVICE

Albuterol using static chambers

Static then Anti-static for Albuterol

static then antistatic albuterol

Group Type EXPERIMENTAL

Static then anti-static chamber

Intervention Type DEVICE

albuterol with Static then anti-static chambers

Interventions

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anti-static then static

Albuterol using static chambers

Intervention Type DEVICE

Static then anti-static chamber

albuterol with Static then anti-static chambers

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Miracle Network

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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Children's Miracle Network UFl

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 103-2008

Identifier Type: -

Identifier Source: org_study_id

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