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Completed

NCT Number: NCT01888549

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

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

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Key information

Conditions

Chronic Cough Caused by Gastroesophageal Reflux Chronic Cough Cough Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam severance hospita

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

High-dose PPI

Drug

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

standard PPI

Drug

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

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2013
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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