Trial Outcomes & Findings for A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients (NCT NCT00819637)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

1 hour

Results posted on

2023-05-24

Participant Flow

Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department

Participant milestones

Participant milestones
Measure	Arformoterol 1 Dose, Placebo 2 Doses	Arformoterol 3 Doses	Levalbuterol 3 Doses
Overall Study STARTED	2	0	0
Overall Study COMPLETED	2	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arformoterol 1 Dose, Placebo 2 Doses n=2 Participants	Arformoterol 3 Doses	Levalbuterol 3 Doses	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Study was terminated after two patients enrolled. Data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Population: The study was terminated early and therefore outcome measures were not obtained.

The study was terminated early and therefore secondary outcome measures were not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained.

The study was terminated early and therefore secondary outcome measures were not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Population: The study was terminated early, therefore outcome measures were not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Population: The study was terminated early and therefore outcome measures were not obtained

The study was terminated early and therefore secondary outcome measures were not obtained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Population: The study was terminated early and therefore outcome measures were not obtained

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hour

Population: The study was terminated early and therefore outcome measures were not obtained

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained

The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained.

2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 hours

Population: The study was terminated early and therefore outcome measures were not obtained.

Outcome measures

Outcome data not reported

Adverse Events

Arformoterol 1 Dose, Placebo 2 Doses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arformoterol 3 Doses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levalbuterol 3 Doses

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

Richard M Nowak MD

Henry Ford Health System, Detroit, Michigan

Phone: 313 881 0023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place