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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01888549
Enrollment
48
Registered
2013-06-27
Start date
2012-02-29
Completion date
2016-02-29
Last updated
2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cough Caused by Gastroesophageal Reflux

Keywords

Chronic cough, proton pump inhibitor, GERD, nonacid reflux,

Brief summary

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

Interventions

DRUGHigh-dose PPI

:40mg, po(per oral) 2times.day, 8weeks

DRUGstandard PPI

: 40mg, po(per oral) 1times.day, 8weeks

DRUGplacebo

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in LCQ score and cough VAS, comparing PPI-treated group to placebochange in LCQ score after 4 weeks and 8 weeks

Secondary

MeasureTime frame
change in LCQ score and cough VAS, comparing PPI-treated group to placebochange in cough VAS after 4weeks and 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026