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How Different Beta-2 Receptor Genotypes Affect an Asthmatic's Response to Regular Salmeterol Treatment (SECS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00595361
First received: January 7, 2008
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: July 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: salmeterol

  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
No text entered.

Reporting Groups
  Description
Arg/Arg

Arg/Arg subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks

Gly/Gly

Gly/Gly subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks


Participant Flow:   Overall Study
    Arg/Arg     Gly/Gly  
STARTED     12     18  
COMPLETED     12     18  
NOT COMPLETED     0     0  



  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
Arg/Arg

Arg/Arg subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks

Gly/Gly

Gly/Gly subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks

Total Total of all reporting groups

Baseline Measures
    Arg/Arg     Gly/Gly     Total  
Number of Participants  
[units: participants]
  12     14     26  
Age  
[units: years]
Mean ± Standard Deviation
  25.8  ± 2.4     27.2  ± 1.4     26.6  ± 1.3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     14     26  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     10     10     20  
Male     2     4     6  
Region of Enrollment  
[units: participants]
     
United States     12     14     26  



  Outcome Measures

1.  Primary:   Comparison of the Maximum Percent Fall in FEV1 After Exercise Challenge at the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Patients   [ Time Frame: 2 weeks ]

2.  Secondary:   Comparison of the Maximum Percent Fall in FEV1 From Pre-salmeterol Baseline to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Comparison of the Maximum Percent Fall in FEV1 After 1st Dose of Salmeterol to the End of the 2-week Treatment Period Between Arg/Arg and Gly/Gly Subjects   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elliot Israel, MD
Organization: Brigham and Women's Hopsital
phone: 617-732-8110
e-mail: eisrael@partners.org


Publications of Results:

Publications automatically indexed to this study:

Responsible Party: Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00595361     History of Changes
Other Study ID Numbers: 2007-P-002199
Study First Received: January 7, 2008
Results First Received: July 16, 2014
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board