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

Yonsei University

Status: Completed

Conditions: Chronic Cough Caused by Gastroesophageal Reflux

Treatments: Drug: placebo; Drug: High-dose PPI; Drug: standard PPI

Study type: Interventional

Funder types: Other

Identifiers

NCT01888549

3-2011-0103

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

arm1-High dose PPI

Experimental group

Treatment:

Drug: High-dose PPI

arm2-standard dose PPI

Active Comparator group

Treatment:

Drug: standard PPI

arm3-placebo

Placebo Comparator group

Description:

Esomeprazole placebo

Treatment:

Drug: placebo