Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00755079
First received: September 15, 2008
Last updated: July 31, 2014
Last verified: July 2014
Results First Received: June 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Spinal Cord Injury
Interventions: Drug: extended release beta-2 adrenergic agonist
Drug: placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Control

group of persons with spinal cord injury will receive blinded placebo capsule

placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.

Active Drug

group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule

extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.


Participant Flow:   Overall Study
    Placebo Control     Active Drug  
STARTED     18     22  
COMPLETED     17     16  
NOT COMPLETED     1     6  
Lost to Follow-up                 1                 3  
Adverse Event                 0                 1  
Withdrawal by Subject                 0                 2  



  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.
No text entered.

Reporting Groups
  Description
Placebo

group of persons with spinal cord injury will receive blinded placebo capsule

placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.

Active Drug

group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule

extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.

Total Total of all reporting groups

Baseline Measures
    Placebo     Active Drug     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age  
[units: years]
Mean ± Standard Deviation
  42.24  ± 9.53     42.75  ± 14.74     42.48  ± 12.14  
Gender  
[units: participants]
     
Female     1     1     2  
Male     16     15     31  
Region of Enrollment  
[units: participants]
     
United States     17     16     33  



  Outcome Measures
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1.  Primary:   Inspiratory Respiratory Muscle Strength   [ Time Frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. ]

2.  Secondary:   Expiratory Respiratory Muscle Strength   [ Time Frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment. ]


  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
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  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: Joshua Hobson, MS
Organization: VAHSRD
phone: (718) 584-9000 ext 3129
e-mail: joshua.hobson@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00755079     History of Changes
Other Study ID Numbers: B4162-C
Study First Received: September 15, 2008
Results First Received: June 16, 2014
Last Updated: July 31, 2014
Health Authority: United States: Federal Government