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

Primary Purpose

Chronic Cough Caused by Gastroesophageal Reflux

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

High-dose PPI

standard PPI

placebo

About this trial

This is an interventional treatment trial for Chronic Cough Caused by Gastroesophageal Reflux focused on measuring Chronic cough, proton pump inhibitor, GERD, nonacid reflux,

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Gangnam severance hospita

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

arm1-High dose PPI

arm2-standard dose PPI

arm3-placebo

Arm Description

Esomeprazole placebo

Outcomes

Primary Outcome Measures

change in LCQ score and cough VAS, comparing PPI-treated group to placebo

Secondary Outcome Measures

change in LCQ score and cough VAS, comparing PPI-treated group to placebo

Full Information

NCT ID

NCT01888549

First Posted

June 25, 2013

Last Updated

June 22, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01888549

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Cough Caused by Gastroesophageal Reflux

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

arm1-High dose PPI

Arm Type

Experimental

Arm Title

arm2-standard dose PPI

Arm Type

Active Comparator

Arm Title

arm3-placebo

Arm Type

Placebo Comparator

Arm Description

Esomeprazole placebo

Intervention Type

Drug

Intervention Name(s)

High-dose PPI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

standard PPI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

change in LCQ score and cough VAS, comparing PPI-treated group to placebo

Time Frame

change in cough VAS after 4weeks and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Gangnam severance hospita

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29016626

Citation

Park HJ, Park YM, Kim JH, Lee HS, Kim HJ, Ahn CM, Byun MK. Effectiveness of proton pump inhibitor in unexplained chronic cough. PLoS One. 2017 Oct 10;12(10):e0185397. doi: 10.1371/journal.pone.0185397. eCollection 2017.

Results Reference

derived

Learn more about this trial

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

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