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Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT01888549
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial

Condition or disease Intervention/treatment Phase
Chronic Cough Caused by Gastroesophageal Reflux Drug: High-dose PPI Drug: standard PPI Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough GERD

Arm Intervention/treatment
Experimental: arm1-High dose PPI Drug: High-dose PPI
:40mg, po(per oral) 2times.day, 8weeks

Active Comparator: arm2-standard dose PPI Drug: standard PPI
: 40mg, po(per oral) 1times.day, 8weeks

Placebo Comparator: arm3-placebo
Esomeprazole placebo
Drug: placebo



Primary Outcome Measures :
  1. change in LCQ score and cough VAS, comparing PPI-treated group to placebo [ Time Frame: change in LCQ score after 4 weeks and 8 weeks ]

Secondary Outcome Measures :
  1. change in LCQ score and cough VAS, comparing PPI-treated group to placebo [ Time Frame: change in cough VAS after 4weeks and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ages of 18 and 70 years had chronic cough of >8 weeks in duration

Exclusion Criteria:

1. abnormal chest X ray, PNS view 2. previous surgical or endoscopic antireflux procedure 3. previous aerodigestive malignancy or Barrett's oesophagus 4. current smokers or ex-smok-ers (defined as those who quit smoking <3 months prior to study enrolment or those who have quit, but have a 20 pack year smoking history) 5. Malignancy History (lung cancer, esophageal cancer etc.) 6. upper respiratory infection within 8 weeks of study enrolment 7. currently using a PPI, H2 blocker, beta-blocker, angiotensin-converting enzyme inhibitor, corticosteroid, methylxanthine, inhaled beta-agonist, anti-inflammatory agent or anticholinesterase drug at time of enrolment


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888549


Locations
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Korea, Republic of
Gangnam severance hospita
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01888549    
Other Study ID Numbers: 3-2011-0103
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Keywords provided by Yonsei University:
Chronic cough, proton pump inhibitor, GERD, nonacid reflux,
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Cough
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory