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

University of Florida

Status: Completed

Conditions: Asthma

Treatments: Device: anti-static then static; Device: Static then anti-static chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT01111110

Children's Miracle Network UFl (Other Grant/Funding Number)

IRB 103-2008

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Anti-static then Static for Albuterol

Experimental group

Description:

albuterol anti-static first then static chamber second.

Treatment:

Device: anti-static then static

Static then Anti-static for Albuterol

Experimental group

Description:

static then antistatic albuterol

Treatment:

Device: Static then anti-static chamber