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Unable to enroll r/t study design & staffing issues. The trial terminated.
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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arformoterol 3 doses | Experimental |
| |
| Arformoterol 1 dose, placebo 2 doses | Experimental |
| |
| Levalbuterol 3 doses | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arformoterol (RR formoterol) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Nowak, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital Emergency Department | Detroit | Michigan | 48202 | United States |
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Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department
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| ID | Title | Description |
|---|---|---|
| FG000 | Arformoterol 1 Dose, Placebo 2 Doses | |
| FG001 | Arformoterol 3 Doses | |
| FG002 | Levalbuterol 3 Doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study was closed after 2 patients were enrolled but the study data was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arformoterol 1 Dose, Placebo 2 Doses | |
| BG001 | Arformoterol 3 Doses | |
| BG002 | Levalbuterol 3 Doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug | Study was terminated after two patients enrolled. Data not collected. | Posted | 1 hour |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arformoterol 1 Dose, Placebo 2 Doses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard M Nowak MD | Henry Ford Health System, Detroit, Michigan | 313 881 0023 | rnowak1@hfhs.staff |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D064412 | Levalbuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| placebo | Drug | Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses. |
|
| levalbuterol | Drug | Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses. |
|
|
| 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. |
| 5 hours |
| The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | 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. | 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 | 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 | 5 hour |
| The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) | 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. | 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. | 5 hours |
| All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles | 5 hours |
| Pharmacokinetics of Arformoterol in This Clinical Setting | 5 hours |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
| Secondary | 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. | The study was terminated early and therefore outcome measures were not obtained. | Posted | 1 hour |
|
|
| Secondary | 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. | The study was terminated early and therefore outcome measures were not obtained. | Posted | 5 hours |
|
|
| Secondary | The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug | The study was terminated early, therefore outcome measures were not obtained. | Posted | 1 hour |
|
|
| Secondary | 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. | The study was terminated early and therefore outcome measures were not obtained | Posted | 1 hour |
|
|
| Secondary | 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 | The study was terminated early and therefore outcome measures were not obtained | Posted | 1 hour |
|
|
| Secondary | 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 | The study was terminated early and therefore outcome measures were not obtained | Posted | 5 hour |
|
|
| Secondary | The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative) | The study was terminated early and therefore outcome measures were not obtained | Posted | 5 hours |
|
|
| Secondary | 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. | The study was terminated early and therefore outcome measures were not obtained | Posted | 5 hours |
|
|
| Secondary | 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. | The study was terminated early and therefore outcome measures were not obtained. | Posted | 5 hours |
|
|
| Secondary | All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles | The study was terminated early and therefore outcome measures were not obtained | Posted | 5 hours |
|
|
| Secondary | Pharmacokinetics of Arformoterol in This Clinical Setting | The study was terminated early and therefore outcome measures were not obtained. | Posted | 5 hours |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Arformoterol 3 Doses | 0 | 0 | 0 | 0 |
| EG002 | Levalbuterol 3 Doses | 0 | 0 | 0 | 0 |
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| D000588 |
| Amines |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |