Chronic Cough Caused by Gastroesophageal RefluxNCT01888549
Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial
A study testing High-dose PPI and standard PPI in people with Chronic Cough Caused by Gastroesophageal Reflux, run by Yonsei University at 1 site in South Korea.
Trial summary
Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Cough Caused by Gastroesophageal Reflux
- What is being tested?
- High-dose PPI and standard PPI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages of 18 and 70 years had chronic cough of >8 weeks in duration
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial
- Being tested
- High-dose PPI, standard PPI, placebo
- Keywords
- Chronic cough, proton pump inhibitor, GERD, nonacid reflux,
- Medical subject headings
- Chronic Cough, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose PPIDrug
:40mg, po(per oral) 2times.day, 8weeks
standard PPIDrug
: 40mg, po(per oral) 1times.day, 8weeks
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| arm1-High dose PPI | Experimental | Not described Receives: Drug: High-dose PPI |
| arm2-standard dose PPI | Active comparator | Not described Receives: Drug: standard PPI |
| arm3-placebo | Placebo comparator | Esomeprazole placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in LCQ score and cough VAS, comparing PPI-treated group to placebo
Measured: 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
Measured: change in cough VAS after 4weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Cough Caused by Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888549
- Sponsor's protocol ID
- 3-2011-0103
- Status last verified
- Jun 2016
- First submitted
- 25 Jun 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29016626
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01888549
- Acronym / sponsor ID
- 3-2011-0103
- Keywords
- Chronic cough, proton pump inhibitor, GERD, nonacid reflux,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arm1-High dose PPI | Experimental | Drug: High-dose PPI |
| arm2-standard dose PPI | Active comparator | Drug: standard PPI |
| arm3-placebo | Placebo comparator | Drug: placeboEsomeprazole placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ages of 18 and 70 years had chronic cough of >8 weeks in duration
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose PPI:40mg, po(per oral) 2times.day, 8weeks | Drug | arm1-High dose PPI |
| standard PPI: 40mg, po(per oral) 1times.day, 8weeks | Drug | arm2-standard dose PPI |
| placebo | Drug | arm3-placebo |
Primary outcome
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
1 secondary outcome
change in LCQ score and cough VAS, comparing PPI-treated group to placebo
Time frame: change in cough VAS after 4weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 29016626Park 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose PPI and standard PPI in people with Chronic Cough Caused by Gastroesophageal Reflux, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01888549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.