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

Study Overview
=================
Brief Summary
-----------------
Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: anti-static then static
* Device: Static then anti-static chamber


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-static then Static for Albuterol<br>albuterol anti-static first then static chamber second. | Device: anti-static then static<br>* Albuterol using static chambers<br>|
| Experimental: Static then Anti-static for Albuterol<br>static then antistatic albuterol | Device: Static then anti-static chamber<br>* albuterol with Static then anti-static chambers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |