Trial Outcomes & Findings for Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm (NCT NCT01111110)

Results Overview

(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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

15 minutes after 2 puffs of albuterol

Results posted on

2022-02-28

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Anti-static/Static albuterol with anti-static chamber then Static on another night	Static/Antistatic albuterol with static chamber then with antistatic chamber on another night.
Overall Study STARTED	3	4
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anti-static/Static n=3 Participants albuterol with anti-static chamber then Static on another night	Static/Antistatic n=4 Participants albuterol with static chamber then with antistatic chamber on another night.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	21.5 years STANDARD_DEVIATION 2.8 • n=7 Participants	24.4 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

(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

Outcome measures

Outcome measures
Measure	Anti-static/Static n=3 Participants albuterol with anti-static chamber then Static on another night	Static/Antistatic n=4 Participants albuterol with static chamber then with antistatic chamber on another night.
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	26.7 percentage of change from 4AM Standard Error 20.3

PRIMARY outcome

Timeframe: 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.

(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

Outcome measures

Outcome measures
Measure	Anti-static/Static n=3 Participants albuterol with anti-static chamber then Static on another night	Static/Antistatic n=4 Participants albuterol with static chamber then with antistatic chamber on another night.
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	31.8 percentage of change from 4AM Standard Deviation 19.8

PRIMARY outcome

Timeframe: 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.

(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

Outcome measures

Outcome measures
Measure	Anti-static/Static n=3 Participants albuterol with anti-static chamber then Static on another night	Static/Antistatic n=4 Participants albuterol with static chamber then with antistatic chamber on another night.
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	31.9 percentage of change from 4AM Standard Deviation 19.3

Adverse Events

Static

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Antistatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Sreekala Prabhakaran. Clinical Assistant Professor Pediatrics

University of Florida

Phone: 352-273-8381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place