A Phase 4 interventional study of arformoterol (RR formoterol) and placebo in Acute Asthma, sponsored by Henry Ford Health System. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the best dose of nebulized arformoterol, a quick onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics presenting to the the Emergency Department. Also this study will evaluate the side effect and safety profile of arformoterol when used in this situation.
Acute bronchospasm associated with exacerbations of asthma is a common problem. Currently the mainstay of treatment is inhalation albuterol, either levalbuterol or racemic mixture, in repetitive fashion depending on the resolution of the airways obstruction. Formoterol is a long-acting (>12 hours) selective beta2-agonist that has a very rapid onset of bronchodilatation (\<3 minutes and thus similar to that produced by albuterol). Patients with acute bronchospasm could benefit from the prn use of formoterol as they would receive acute relief of their symptoms and this would last for a prolonged time period. Additionally formoterol has been reported to be 28-109 times as potent as albuterol and safe at doses of 54ug in healthy subjects and asthmatics. Racemic formoterol structurally has 2 chiral centers and thus is composed of 4 enantiomers. The RR form (or arformoterol) is the active bronchodilator and it is not clear what the physiologic actions of the other 3 enantiomers are. This study is the first to evaluate nebulized arformoterol solution for therapy of acute asthmatics presenting to the Emergency Department.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 2 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: arformoterol (RR formoterol)
Drug: arformoterol (RR formoterol) · Drug: placebo
Drug: levalbuterol
Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses. Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
Also known as: Brovana
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
Also known as: Xopenex
The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug
Time frame: 1 hour
Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups
The study was terminated early and therefore secondary outcome measures were not obtained.
Time frame: 1 hour
Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.
The study was terminated early and therefore secondary outcome measures were not obtained.
Time frame: 5 hours
The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Time frame: 1 hour
The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
The study was terminated early and therefore secondary outcome measures were not obtained.
Time frame: 1 hour
The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Time frame: 1 hour
The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This
Time frame: 5 hour
The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)
Time frame: 5 hours
Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)
The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.
Time frame: 5 hours
Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments
2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.
Time frame: 5 hours
All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles
Time frame: 5 hours
Pharmacokinetics of Arformoterol in This Clinical Setting
Time frame: 5 hours
Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department
| Milestone | Arformoterol 1 Dose, Placebo 2 Doses | Arformoterol 3 Doses | Levalbuterol 3 Doses |
|---|---|---|---|
| Started | 2 | 0 | 0 |
| Completed | 2 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
No measurements were reported for this outcome.
The study was terminated early and therefore secondary outcome measures were not obtained.
No measurements were reported for this outcome.
The study was terminated early and therefore secondary outcome measures were not obtained.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
The study was terminated early and therefore secondary outcome measures were not obtained.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.
No measurements were reported for this outcome.
2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arformoterol 1 Dose, Placebo 2 Doses | — | 0/2 (0%) | 0/2 (0%) |
| Arformoterol 3 Doses | — | — | — |
| Levalbuterol 3 Doses | — | — | — |
This study was closed after 2 patients were enrolled but the study data was not collected.
| Age, Categorical(Participants) | Arformoterol 1 Dose, Placebo 2 Doses | Arformoterol 3 Doses | Levalbuterol 3 Doses | Total |
|---|---|---|---|---|
| <=18 years | 0 | — | — | 0 |
| Between 18 and 65 years | 2 | — | — | 2 |
| >=65 years | 0 | — | — | 0 |
| Sex: Female, Male(Participants) | Arformoterol 1 Dose, Placebo 2 Doses | Arformoterol 3 Doses | Levalbuterol 3 Doses | Total |
|---|---|---|---|---|
| Female | 1 | — | — | 1 |
| Male | 1 | — | — | 1 |
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Henry Ford Health System