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The Utility of Nexium in Chronic Cough and Reflux Disease
This study has been completed.
Study NCT00287339   Information provided by University of North Carolina, Chapel Hill

First Received on February 3, 2006.   Last Updated on January 6, 2012   History of Changes
Results First Received: May 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cough
GERD
Interventions: Drug: Esomeprazole
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
recruited from hospital clinics - subjects with chronic cough.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
. After initial eligibility screening, all consenting participants entered a 7-day run-in period, during which all subjects took a placebo pill twice a day, for the purpose of ensuring compliance with study medication and assessment of cough severity under baseline conditions.

Reporting Groups
  Description
Esomeprazole Arm Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
Placebo Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.

Participant Flow:   Overall Study
    Esomeprazole Arm     Placebo  
STARTED     22     18  
COMPLETED     22     18  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Esomeprazole Arm Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
Placebo Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.

Baseline Measures
    Esomeprazole Arm     Placebo     Total  
Number of Participants  
[units: participants]
 		  22     18     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     20     17     37  
>=65 years     2     1     3  
Age  
[units: years]
Mean ± Standard Deviation 		  49.5  ± 12     51.0  ± 11.6     50  ± 11.7  
Gender  
[units: participants]
 		     
Female     16     15     31  
Male     6     3     9  
Region of Enrollment  
[units: participants]
 		     
United States     22     18     40  



  Outcome Measures

1.  Primary:   Change in Cough-Specific Quality of Life Questionnaire   [ Time Frame: baseline and 12 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


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
This study was performed at a single center, and participants were mostly female and white, which may limit generalizability. The number of subjects in some patient subgroups was small.  


Results Point of Contact:  
Name/Title: Dr Nicholas Shaheen
Organization: UNC_ChapelHill
phone: 919 9667047
e-mail: nshaheen@med.unc.edu


Publications of Results:
Shaheen NJ, Crockett SD, Bright SD, Madanick RD, Buckmire R, Couch M, Dellon ES, Galanko JA, Sharpless G, Morgan DR, Spacek MB, Heidt-Davis P, Henke D. Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(2):225-34. Epub 2010 Nov 17.


Responsible Party: Nicholas Shaheen, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00287339     History of Changes
Other Study ID Numbers: AZ COUGH
Study First Received: February 3, 2006
Results First Received: May 11, 2011
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board





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