Acute AsthmaPhase 4NCT00819637
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
A Phase 4 study testing arformoterol (RR formoterol) and levalbuterol in people with Acute Asthma, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Asthma
- What is being tested?
- arformoterol (RR formoterol) and levalbuterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- FEV1 between 20 and 60% predicted after having received 5 mg of albuterol and 0.5 mg of atrovent as nebulized standard of care therapy
- Male or female between the ages of 18 and 45
- Asthma diagnosed by a physician and present for at least 6 months
- oxygen saturation greater or equal to 90% on room air
- Non smoker or < 10 pack-year history
- No other cause for wheezing/sob as determined by the treating physician
Who cannot join
- Clinical evidence or history of hepatic, renal, cardiovascular, GI, endocrine, metabolic or CNS disease which might interfere with the conduct of the study
- Acute respiratory failure or other significant pathology of the pulmonary system
- Female subjects who are pregnant or lactating
- Currently receiving therapy for a psychiatric disorder
- Subjects with a known sensitivity to formoterol (racemic or RR) or albuterol (racemic or lev)
- History of hospitalization for asthma within 2 months or treatment for acute asthma in an ED within 2 weeks of study entry
- Past or current use of disallowed medications
- Participation in an investigational study within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Hospital Emergency Department
Detroit, Michigan, 48202
About this study
Official title: A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients Presenting to the Emergency Department and to Evaluate Its Side Effect and Safety Profile When Used in This Clinical Situation.
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.
Read the detailed description
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.
- Conditions
- Acute Asthma
- Being tested
- arformoterol (RR formoterol), placebo, levalbuterol
- Keywords
- Acute asthma, Arformoterol, Long acting beta agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arformoterol (RR formoterol)Drug
Also called Brovana
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.
placeboDrug
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
levalbuterolDrug
Also called Xopenex
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Arformoterol 3 doses | Experimental | Not described Receives: Drug: arformoterol (RR formoterol) |
| Arformoterol 1 dose, placebo 2 doses | Experimental | Not described Receives: Drug: arformoterol (RR formoterol); Drug: placebo |
| Levalbuterol 3 doses | Active comparator | Not described Receives: Drug: levalbuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug
Measured: 1 hour
Secondary outcomes (11)
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.
Measured: 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.
Measured: 5 hours
The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Measured: 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.
Measured: 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
Measured: 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
Measured: 5 hour
The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)
Measured: 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.
Measured: 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.
Measured: 5 hours
All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles
Measured: 5 hours
Pharmacokinetics of Arformoterol in This Clinical Setting
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Unable to enroll r/t study design \& staffing issues. The trial terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard M Nowak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819637
- Sponsor's protocol ID
- ASRC947
- Status last verified
- Apr 2023
- First submitted
- 8 Jan 2009
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients Presenting to the Emergency Department and to Evaluate Its Side Effect and Safety Profile When Used in This Clinical Situation.
- ClinicalTrials.gov ID
- NCT00819637
- Acronym / sponsor ID
- ASRC947
- Conditions
- Acute Asthma
- Keywords
- Acute asthma, Arformoterol, Long acting beta agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll r/t study design \& staffing issues. The trial terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Sumitomo Pharma America, Inc.
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Posted 29 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arformoterol 3 doses | Experimental | Drug: arformoterol (RR formoterol) |
| Arformoterol 1 dose, placebo 2 doses | Experimental | Drug: arformoterol (RR formoterol), Drug: placebo |
| Levalbuterol 3 doses | Active comparator | Drug: levalbuterol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent
- FEV1 between 20 and 60% predicted after having received 5 mg of albuterol and 0.5 mg of atrovent as nebulized standard of care therapy
- Male or female between the ages of 18 and 45
- Asthma diagnosed by a physician and present for at least 6 months
- oxygen saturation greater or equal to 90% on room air
Key exclusion criteria (8 listed)
- Clinical evidence or history of hepatic, renal, cardiovascular, GI, endocrine, metabolic or CNS disease which might interfere with the conduct of the study
- Acute respiratory failure or other significant pathology of the pulmonary system
- Female subjects who are pregnant or lactating
- Currently receiving therapy for a psychiatric disorder
- Subjects with a known sensitivity to formoterol (racemic or RR) or albuterol (racemic or lev)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arformoterol (RR formoterol)Also: BrovanaGroup 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. | Drug | Arformoterol 1 dose, placebo 2 doses, Arformoterol 3 doses |
| placeboGroup 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses. | Drug | Arformoterol 1 dose, placebo 2 doses |
| levalbuterolAlso: XopenexGroup 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses. | Drug | Levalbuterol 3 doses |
Primary outcome
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
11 secondary outcomes
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
Time frame: 1 hour
Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.
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
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)
Time frame: 5 hours
Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Nowak, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing arformoterol (RR formoterol) and levalbuterol in people with Acute Asthma, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.