Asthma
Conditions
Brief summary
Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
Interventions
DEVICEanti-static then static
Albuterol using static chambers
DEVICEStatic then anti-static chamber
albuterol with Static then anti-static chambers
Sponsors
Children's Miracle Network
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment process was done in the Asthma Research Lab. Note that 88 were screened and 4 subjects randomized but determined to be ineligile before starting treatment. They are amongst the screen failures.
Pre-assignment details
Subjects qualified in the screening visit went into a 7 day run-in-period They needed to have a 20% peak flow overnight drop on 3/7 nights in order to qualify for overnight stays in the Clinical Research Center. Arms are identified by order of treatment assignment. Any other designation is not consistent with our protocol requirements.
Participants by arm
| Arm | Count |
|---|---|
| Anti-static/Static albuterol with anti-static chamber then Static on another night | 3 |
| Static/Antistatic albuterol with static chamber then with antistatic chamber on another night. | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Total | Anti-static/Static | Static/Antistatic |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 24.4 years STANDARD_DEVIATION 7.2 | 28.3 years STANDARD_DEVIATION 11.1 | 21.5 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 7 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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
Time frame: fifteen minutes after 1 puff of albuterol
Population: Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-static/Static | Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | -15.4 percentage of change from 4AM | Standard Error 12.2 |
| Static/Antistatic | Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | 26.7 percentage of change from 4AM | Standard Error 20.3 |
Comparison: (Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.p-value: 0.02695% CI: [3.8, 41.7]t-test, 2 sided
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
Time frame: 15 minutes after 2 puffs of albuterol
Population: Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-static/Static | Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | -15.3 percentage of change from 4AM | Standard Deviation 14.1 |
| Static/Antistatic | Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | 31.8 percentage of change from 4AM | Standard Deviation 19.8 |
Comparison: Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.p-value: 0.01895% CI: [6, 41]t-test, 2 sided
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
Time frame: fifteen minutes after 4 puffs of albuterol
Population: Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-static/Static | Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | -17.5 percentage of change from 4AM | Standard Deviation 13.6 |
| Static/Antistatic | Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1. | 31.9 percentage of change from 4AM | Standard Deviation 19.3 |
Comparison: Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1p-value: 0.01395% CI: [7.7, 41.7]t-test, 2 sided