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

University of Florida88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Asthma

Interventions

anti-static then staticDEVICE

Albuterol using static chambers

Static then anti-static chamberDEVICE

albuterol with Static then anti-static chambers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: fifteen minutes after 1 puff of albuterol

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

Time frame: 15 minutes after 2 puffs of albuterol

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

Time frame: fifteen minutes after 4 puffs of albuterol

Data from ClinicalTrials.gov

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