Trial Outcomes & Findings for Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma (NCT NCT05363670)
NCT ID: NCT05363670
Last Updated: 2026-07-14
Results Overview
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From baseline (timepoints 0) to 1 hour
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
Sequence 1
First intervention - 2 mg dose of ARS-1
Seven day washout
Second intervention - albuterol MDI (180 mcg)
Seven day washout
Third intervention - placebo
Seven day washout
Fourth intervention - 1 mg dose of ARS-1
|
Sequence 2
First intervention - ARS-1 1 mg dose
Seven day washout
Second intervention - placebo
Seven day washout
Third intervention - albuterol MDI (180 mcg)
Seven day washout
Fourth intervention - ARS-1 2 mg dose
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Interventional Treatment
n=18 Participants
Each subject received the following treatments in a randomized sequence:
2 mg dose of ARS-1
albuterol MDI (180 mcg)
placebo
1 mg dose of ARS-1
Albuterol MDI: 180 mcg
Placebo: Placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From baseline (timepoints 0) to 1 hourDifference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Outcome measures
| Measure |
ARS-1 1mg
n=18 Participants
1 mg dose of ARS-1
|
ARS-1 2mg
n=18 Participants
2 mg dose of ARS-1
|
Placebo
n=18 Participants
Placebo
|
Albuterol
n=18 Participants
Albuterol MDI 180 mcg
|
|---|---|---|---|---|
|
Effect of ARS-1 Versus Albuterol and Placebo
|
0.150 FEV1 L per hour
Standard Deviation 0.223
|
0.233 FEV1 L per hour
Standard Deviation 0.216
|
-0.002 FEV1 L per hour
Standard Deviation 0.118
|
0.378 FEV1 L per hour
Standard Deviation 0.265
|
Adverse Events
ARS-1 1mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ARS-1 2mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Albuterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARS-1 1mg
n=18 participants at risk
1 mg dose of ARS-1
|
ARS-1 2mg
n=18 participants at risk
2 mg dose of ARS-1
|
Placebo
n=18 participants at risk
Placebo
|
Albuterol
n=18 participants at risk
Albuterol MDI 180 mcg
|
|---|---|---|---|---|
|
General disorders
Nasal discomfort
|
27.8%
5/18 • Number of events 5 • 5 hours
|
38.9%
7/18 • Number of events 7 • 5 hours
|
5.6%
1/18 • Number of events 1 • 5 hours
|
0.00%
0/18 • 5 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place