A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00819637 |
Recruitment Status
:
Terminated
(Unable to enroll r/t study design & staffing issues. The trial terminated.)
First Posted
: January 9, 2009
Results First Posted
: June 29, 2010
Last Update Posted
: April 6, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Asthma | Drug: arformoterol (RR formoterol) Drug: placebo Drug: levalbuterol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Arformoterol 3 doses |
Drug: arformoterol (RR formoterol)
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. Other Name: Brovana
|
Experimental: Arformoterol 1 dose, placebo 2 doses |
Drug: arformoterol (RR formoterol)
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. Other Name: Brovana
Drug: placebo
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.
|
Active Comparator: Levalbuterol 3 doses |
Drug: levalbuterol
Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
Other Name: 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 [ 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 ]The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.
- Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments [ Time Frame: 5 hours ]2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819637
United States, Michigan | |
Henry Ford Hospital Emergency Department | |
Detroit, Michigan, United States, 48202 |
Principal Investigator: | Richard M Nowak, MD | Henry Ford Health System |
Responsible Party: | Richard M Nowak, Sr. Staff Physician DEM, Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00819637 History of Changes |
Other Study ID Numbers: |
ASRC947 |
First Posted: | January 9, 2009 Key Record Dates |
Results First Posted: | June 29, 2010 |
Last Update Posted: | April 6, 2015 |
Last Verified: | March 2015 |
Keywords provided by Richard M Nowak, Henry Ford Health System:
Acute asthma Arformoterol Long acting beta agonists |
Additional relevant MeSH terms:
Formoterol Fumarate Albuterol Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |