Trial Outcomes & Findings for Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay (NCT NCT00643578)

Results Overview

The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

3-7 days after visits 1 and 2

Results posted on

2011-12-05

Participant Flow

Between April and November, 2008, the UF Asthma Research Lab recruited 37 patients for study.

Of the 37 subjects who signed informed consent, 25 did not meet inclusion/exclusion criteria. The provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second (PC20FEV1) was not less than or equal to 4 mg/mL.

Participant milestones

Participant milestones
Measure	Formoterol 12 First a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol	Formoterol 24 First a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
Overall Study STARTED	6	6
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	36.8 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-7 days after visits 1 and 2

Population: Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.

The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.

Outcome measures

Outcome measures
Measure	12 Mcg Formoterol n=10 Participants low dose	24 Mcg Formoterol n=10 Participants high dose
Post-dose PC20	7 mg/mL Interval 2.0 to 22.0	16 mg/mL Interval 5.0 to 45.0

SECONDARY outcome

Timeframe: 1 hour after dose

Population: Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.

The forced expiratory volume in the first second, expressed as a percent predicted.

Outcome measures

Outcome measures
Measure	12 Mcg Formoterol n=10 Participants low dose	24 Mcg Formoterol n=10 Participants high dose
FEV1	88 percent predicted Standard Deviation 12	91 percent predicted Standard Deviation 10

Adverse Events

Formoterol 12

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Formoterol 24

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. Leslie Hendeles

University of Florida Asthma Research Lab

Phone: 352-273-6027

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place