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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111110
• Other study ID #: IRB 103-2008
• Secondary ID: Children's Mirac
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Spasm

Intervention

Device:
• anti-static then static
Albuterol using static chambers
• Static then anti-static chamber
albuterol with Static then anti-static chambers

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Children's Miracle Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	fifteen minutes after 1 puff of albuterol
Primary	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	15 minutes after 2 puffs of albuterol
Primary	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	fifteen minutes after 4 puffs of albuterol