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Assessment of Cough Reflex in Lung Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584077
First Posted: January 2, 2008
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
Results First Submitted: July 3, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Complication of Transplanted Lung

  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
Subjects scheduled to undergo surveillance bronchoscopy were enrolled

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
Lung Transplant Recipients With Stable Lung Function All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response

Participant Flow:   Overall Study
    Lung Transplant Recipients With Stable Lung Function
STARTED   15 
COMPLETED   15 
NOT COMPLETED   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
Lung Transplant Recipients With Stable Lung Function All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response

Baseline Measures
   Lung Transplant Recipients With Stable Lung Function 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Age   49  (8) 
Gender 
[Units: Participants]
 
Female   6 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Evaluate the Presence and Strength of the Cough Reflex in the Lower Airway   [ Time Frame: 15-20 minutes ]

2.  Secondary:   to Assess the Presence and Strength of the Cough Reflex in the Lower Airway for up to One Year   [ Time Frame: 15-20 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
The limitations of this trial are that the results apply to lung transplant recipients


  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: Alexander Duarte, MD
Organization: University of Texas-Galveston
phone: 409-772-2436
e-mail: aduarte@utmb.edu


Publications of Results:

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00584077     History of Changes
Other Study ID Numbers: 00-132
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: July 3, 2013
Results First Posted: September 25, 2015
Last Update Posted: September 25, 2015