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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Device: anti-static then static; Device: Static then anti-static chamber

• Registration Number: NCT01111110
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-04
• Study Completion: 2010-03
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Results First Submitted: 2012-01-10
• Results First Submitted QC: 2012-05-14
• Results First Posted: 2012-06-19
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anti-static then Static for Albuterol	anti-static then static	albuterol anti-static first then static chamber second.
Static then Anti-static for Albuterol	Static then anti-static chamber	static then antistatic albuterol

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States