Trial Outcomes & Findings for Dose-response of Albuterol in Asthmatics (NCT NCT00940927)

Results Overview

ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

15 minutes after each dose

Results posted on

2015-05-05

Participant Flow

Participants were recruited from our asthma research clinic database or newspaper advertisements. Participants were recruited from 07/1993 to 10/1994.

Participants had to withhold inhaled short-acting beta2 agonist or inhaled anticholinergic drugs for 8 h, oral antihistamines for 5 days, theophylline for 24 h, and cromolyn, nedocromil, and inhaled corticosteroids for 2 h prior to the study.

Participant milestones

Participant milestones
Measure	Albuterol Increasing doses of albuterol by MDI and nebulizer solution
Overall Study STARTED	81
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-response of Albuterol in Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albuterol n=81 Participants Increasing doses of albuterol by MDI and nebulizer solution
Age, Categorical <=18 years	31 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=113 Participants
Age, Categorical >=65 years	2 Participants n=113 Participants
Age, Continuous	30.2 years STANDARD_DEVIATION 17.4 • n=113 Participants
Sex: Female, Male Female	45 Participants n=113 Participants
Sex: Female, Male Male	36 Participants n=113 Participants
Region of Enrollment United States	81 participants n=113 Participants

PRIMARY outcome

Timeframe: 15 minutes after each dose

ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol

Outcome measures

Outcome measures
Measure	Albuterol n=81 Participants Increasing doses of albuterol by MDI and nebulizer solution
Effective Dose 50% (ED50)	141 ug

PRIMARY outcome

Timeframe: 15 minutes after each dose

Maximum percentage of predicted FEV1 effect

Outcome measures

Outcome measures
Measure	Albuterol n=81 Participants Increasing doses of albuterol by MDI and nebulizer solution
Effect Maximum (Emax)	24.0 percentage of predicted

Adverse Events

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

Adverse event data not reported

Additional Information

Kathryn Blake, Pharm.D.

Nemours Children's Clinic

Phone: 904 858 3806

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place