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Effect of Nebulized Bronchodilators on Heart Rate

This study has been completed.
Sponsor:
Collaborator:
Genesys Regional Medical Center
Information provided by (Responsible Party):
Fahim Khorfan, MD, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01151579
First received: June 24, 2010
Last updated: September 23, 2015
Last verified: September 2015
Results First Received: March 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Conditions: COPD
Sepsis
Shock
Interventions: Drug: Levalbuterol
Drug: Albuterol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began initially August 21, 2007 at the medical center ICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they had a known allergy or sensitivity to study medications or if baseline heart rate was greater than 110 bpm. Treating physicians detremined the need for and frequency of treatment with bronchodilator therapy. All other medications were allowed.

Reporting Groups
  Description
Nebulized Albuterol 2.5mg Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
Levalbuterol 1.25 Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.

Participant Flow:   Overall Study
    Nebulized Albuterol 2.5mg     Levalbuterol 1.25  
STARTED     58     31  
COMPLETED     46     24  
NOT COMPLETED     12     7  
Physician Decision                 3                 1  
Withdrawal by Subject                 3                 2  
Not meet inclusion criteria                 6                 4  



  Baseline Characteristics
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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.
The number analyzed was determined by the power calculation and based on the number of participants randomized to treatment.

Reporting Groups
  Description
Nebulized Albuterol 2.5mg Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
Levalbuterol 1.25 Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
Total Total of all reporting groups

Baseline Measures
    Nebulized Albuterol 2.5mg     Levalbuterol 1.25     Total  
Number of Participants  
[units: participants]
  58     31     89  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     9     27  
>=65 years     40     22     62  
Age  
[units: years]
Mean (Standard Deviation)
  67.3  (13.1)     67.5  (13.7)     67.3  (13.4)  
Gender  
[units: participants]
     
Female     31     12     43  
Male     27     19     46  
Region of Enrollment  
[units: participants]
     
United States     58     31     89  



  Outcome Measures
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1.  Primary:   Heart Rate in Beats Per Minute   [ Time Frame: Five days ]

2.  Secondary:   Arrhythmias   [ Time Frame: 15 minutes after each treatment for average of 3 to 5 days ]

3.  Secondary:   Total Number of Participants With Arrhythmias   [ Time Frame: Five days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Potential limitations are its single-center site and that the design may not have adequately eliminated all carryover effects from the levalbuterol. However, the number of side effects without carryover would be even lower than we observed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Fahim Khorfan
Organization: Genesys Regional Medical Center
phone: 810-606-7722
e-mail: kbarber@genesys.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fahim Khorfan, MD, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01151579     History of Changes
Other Study ID Numbers: ME 07-0011
Study First Received: June 24, 2010
Results First Received: March 12, 2015
Last Updated: September 23, 2015
Health Authority: United States: Institutional Review Board