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| ID | Type | Description | Link |
|---|---|---|---|
| Children's Miracle Network UFl | Other Grant/Funding Number | Children's Miracle Network, University of Florida |
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| Name | Class |
|---|---|
| Children's Miracle Network | OTHER |
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Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-static then Static for Albuterol | Experimental | albuterol anti-static first then static chamber second. |
|
| Static then Anti-static for Albuterol | Experimental | static then antistatic albuterol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-static then static | Device | Albuterol using static chambers |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-static/Static | albuterol with anti-static chamber then Static on another night |
| FG001 | Static/Antistatic | albuterol with static chamber then with antistatic chamber on another night. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-static/Static | albuterol with anti-static chamber then Static on another night |
| BG001 | Static/Antistatic | albuterol with static chamber then with antistatic chamber on another night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Error | percentage of change from 4AM | fifteen minutes after 1 puff of albuterol |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Static | albuterol with static chamber |
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Nocturnal asthma model is a very sensitive model, but very labor intensive and to get more completed subjects, we might need to do multicenter trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Sreekala Prabhakaran. Clinical Assistant Professor Pediatrics | University of Florida | 352-273-8381 | sprabhakaran@peds.ufl.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Static then anti-static chamber |
| Device |
albuterol with Static then anti-static chambers |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Static/Antistatic | albuterol with static chamber then with antistatic chamber on another night. |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | percentage of change from 4AM | 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 | 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. | Posted | Mean | Standard Deviation | percentage of change from 4AM | fifteen minutes after 4 puffs of albuterol |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Antistatic | albuterol with antistatic chamber. | 0 | 7 | 0 | 7 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Superiority or Other (legacy) |