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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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was open for enrollment from 1/8/09 until 11/19/09. Location was Henry Ford Hospital Emergency Department

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 2 patients were enrolled in this trial

Reporting Groups
  Description
Arformoterol 1 Dose, Placebo 2 Doses No text entered.
Arformoterol 3 Doses No text entered.
Levalbuterol 3 Doses No text entered.

Participant Flow:   Overall Study
    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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arformoterol 1 Dose, Placebo 2 Doses No text entered.
Arformoterol 3 Doses No text entered.
Levalbuterol 3 Doses No text entered.
Total Total of all reporting groups

Baseline Measures
   Arformoterol 1 Dose, Placebo 2 Doses   Arformoterol 3 Doses   Levalbuterol 3 Doses   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   0   0   2 
Age 
[Units: Participants]
       
<=18 years   0         0 
Between 18 and 65 years   2         2 
>=65 years   0         0 
Gender [1] 
[Units: Participants]
       
Female   1         1 
Male   1         1 
[1] Age group 18-65 years of age


  Outcome Measures

1.  Primary:   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 ]

2.  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   [ Time Frame: 1 hour ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug   [ Time Frame: 1 hour ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  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   [ Time Frame: 1 hour ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  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   [ Time Frame: 5 hour ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Pharmacokinetics of Arformoterol in This Clinical Setting   [ Time Frame: 5 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: rnowak1@hfhs.staff



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