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

Not Applicable

Completed

• Conditions: Chronic Cough Caused by Gastroesophageal Reflux
• Interventions: Drug: High-dose PPI; Drug: standard PPI; Drug: placebo

• Registration Number: NCT01888549
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm1-High dose PPI	High-dose PPI	-
arm2-standard dose PPI	standard PPI	-
arm3-placebo	placebo	Esomeprazole placebo

Primary Outcome Measures

Name	Time	Method
change in LCQ score and cough VAS, comparing PPI-treated group to placebo	change in LCQ score after 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
change in LCQ score and cough VAS, comparing PPI-treated group to placebo	change in cough VAS after 4weeks and 8 weeks

Trial Locations

Locations (1)

Gangnam severance hospita; 🇰🇷 Seoul, Korea, Republic of