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

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: anti-static then static (Device); Static then anti-static chamber (Device)

Phase: N/A

Status: Completed

Sponsored by: University of Florida

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

University of Florida, Gainesville, Florida 32610, United States
Additional Information

Starting date: May 2008
Last updated: May 14, 2012

Page last updated: August 23, 2015

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