Trial Outcomes & Findings for Aerosolized Beta-Agonist Isomers in Asthma (NCT NCT02170532)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Results posted on

2014-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerosolized Beta-Agonist Isomers in Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=10 Participants All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
Age, Customized 18 & older	10 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Population: The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.

Outcome measures

Outcome measures
Measure	Levalbuterol + Saline in a Breath Actuated Nebulizer n=10 Participants 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer levalbuterol: 0.5 ml. levalbuterol saline: 0.5ml saline breath actuated nebulizer	Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer n=10 Participants 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer levalbuterol: 0.5 ml. levalbuterol breath actuated nebulizer ipratroprium	Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs n=10 Participants levalbuterol metered dose inhaler (MDI) 2 puffs levalbuterol MDI	Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs n=10 Participants levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs levalbuterol MDI aerochamber max	Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs n=10 Participants levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs levalbuterol MDI aerochamber max
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 30 minutes	20 percentage of change Standard Deviation 23.19	20 percentage of change Standard Deviation 16.55	20 percentage of change Standard Deviation 19.85	19 percentage of change Standard Deviation 20.64	21 percentage of change Standard Deviation 21.10
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 1 hour	28 percentage of change Standard Deviation 31.45	23 percentage of change Standard Deviation 19.24	19 percentage of change Standard Deviation 22.57	20 percentage of change Standard Deviation 24.23	24 percentage of change Standard Deviation 22.62
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 2 hour	26 percentage of change Standard Deviation 32.23	22 percentage of change Standard Deviation 20.64	20 percentage of change Standard Deviation 23.02	19 percentage of change Standard Deviation 26.25	19 percentage of change Standard Deviation 21.47
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 4 hour	15 percentage of change Standard Deviation 29.05	14 percentage of change Standard Deviation 18.89	7 percentage of change Standard Deviation 18.99	6 percentage of change Standard Deviation 16.88	7 percentage of change Standard Deviation 18.51
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 6 hour	0 percentage of change Standard Deviation 18.9	1 percentage of change Standard Deviation 5.23	-5 percentage of change Standard Deviation 5.98	1 percentage of change Standard Deviation 16.05	-6 percentage of change Standard Deviation 11.68
Change in Maximum Forced Expiratory Volume at One Second (FEV1) 8 hour	1 percentage of change Standard Deviation 21.26	9 percentage of change Standard Deviation 13.10	-3 percentage of change Standard Deviation 7.91	0 percentage of change Standard Deviation 15.54	-6 percentage of change Standard Deviation 11.55

SECONDARY outcome

Timeframe: 0 to 8 hours post dose

Outcome measures

Outcome measures
Measure	Levalbuterol + Saline in a Breath Actuated Nebulizer n=10 Participants 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer levalbuterol: 0.5 ml. levalbuterol saline: 0.5ml saline breath actuated nebulizer	Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer n=10 Participants 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer levalbuterol: 0.5 ml. levalbuterol breath actuated nebulizer ipratroprium	Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs n=10 Participants levalbuterol metered dose inhaler (MDI) 2 puffs levalbuterol MDI	Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs n=10 Participants levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs levalbuterol MDI aerochamber max	Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs n=10 Participants levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs levalbuterol MDI aerochamber max
Change in 8 Hour Area-under-the-curve FEV1	5450 percentage of change Standard Deviation 7039	4729 percentage of change Standard Deviation 4275	3893 percentage of change Standard Deviation 4949	3805 percentage of change Standard Deviation 5253	4195 percentage of change Standard Deviation 4795

SECONDARY outcome

Timeframe: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Population: Data for this outcome measure is not reported because the data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Population: Data for this outcome measure is not reported because the data was not collected.

Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Population: Data for this outcome measure is not reported because the data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

All Subjects

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

Neil MacIntyre, MD

Duke University Medical Center

Phone: (919) 681-2720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place