Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial
1 other identifier
interventional
48
1 country
1
Brief Summary
Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJune 24, 2016
June 1, 2016
4 years
June 25, 2013
June 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in LCQ score and cough VAS, comparing PPI-treated group to placebo
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
change in cough VAS after 4weeks and 8 weeks
Study Arms (3)
arm1-High dose PPI
EXPERIMENTALarm2-standard dose PPI
ACTIVE COMPARATORarm3-placebo
PLACEBO COMPARATOREsomeprazole placebo
Interventions
Eligibility Criteria
You may qualify if:
- ages of 18 and 70 years had chronic cough of \>8 weeks in duration
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gangnam severance hospita
Seoul, Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 29016626DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2013
First Posted
June 27, 2013
Study Start
February 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
June 24, 2016
Record last verified: 2016-06