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A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients

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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
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Richard M Nowak, Henry Ford Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Asthma
Interventions Drug: arformoterol (RR formoterol)
Drug: placebo
Drug: levalbuterol
Enrollment 2
Recruitment Details Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department
Pre-assignment Details Only 2 patients were enrolled in this trial
Arm/Group Title Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 2 0 0
Completed 2 0 0
Not Completed 0 0 0
Arm/Group Title Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 2 0 0 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 0 participants 2 participants
<=18 years 0 0
Between 18 and 65 years 2 2
>=65 years 0 0
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 0 participants 2 participants
Female 1 1
Male 1 1
[1]
Measure Description: Age group 18-65 years of age
1.Primary Outcome
Title The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug
Hide Description [Not Specified]
Time Frame 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As the study was terminated with 2 subjects enrolled, those 2 subjects were used for the limited statistical analysis.
Arm/Group Title Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 2 0 0
Median (95% Confidence Interval)
Unit of Measure: percent change
97
(95 to 99)
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 hour
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.
Hide Description [Not Specified]
Time Frame 5 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Hide Description [Not Specified]
Time Frame 1 hour
Outcome Measure Data Not Reported
5.Secondary Outcome
Title The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug
Hide Description [Not Specified]
Time Frame 1 hour
Outcome Measure Data Not Reported
6.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 hour
Outcome Measure Data Not Reported
7.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 5 hour
Outcome Measure Data Not Reported
8.Secondary Outcome
Title The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)
Hide Description [Not Specified]
Time Frame 5 hours
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)
Hide Description 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
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments
Hide Description 2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.
Time Frame 5 hours
Outcome Measure Data Not Reported
11.Secondary Outcome
Title All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles
Hide Description [Not Specified]
Time Frame 5 hours
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Pharmacokinetics of Arformoterol in This Clinical Setting
Hide Description [Not Specified]
Time Frame 5 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arformoterol 1 Dose, Placebo 2 Doses Arformoterol 3 Doses Levalbuterol 3 Doses
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard M Nowak MD
Organization: Henry Ford Health System, Detroit, Michigan
Phone: 313 881 0023
Responsible Party: Richard M Nowak, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00819637     History of Changes
Other Study ID Numbers: ASRC947
First Submitted: January 8, 2009
First Posted: January 9, 2009
Results First Submitted: February 17, 2010
Results First Posted: June 29, 2010
Last Update Posted: April 6, 2015