Chronic Cough (CC)NCT02797756
Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
An observational study of Chronic Cough (CC) and Gastroesophageal Reflux (GER), run by NYU Langone Health at 1 site in United States.
Trial summary
Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Chronic Cough (CC), Gastroesophageal Reflux (GER)
- What is being tested?
- Esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM)
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2014to 12 Dec 2018
- Phase
- Observational
- 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 Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
Who may be able to join
- Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
Who cannot join
- Antibiotic or steroids (inhaled or systemic) use within the prior one-week. Rationale: Antibacterial drugs and immune-modulators are confounders that may impact the microbiome and inflammation. While longer period free of Antibacterial drugs and immune-modulators would be desired, it would be unethical and it is not the usual standard of care to withdraw treatment for longer periods of time.
- Interstitial Lung Disease or pneumonia on X-ray
- Cystic fibrosis
- Primary ciliary dyskinesia
- Immunodeficiency syndromes
- Major airway abnormalities
- Proton pump inhibitor/H2-receptor antagonist therapy within the prior 2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. A case-control study design will be used to study whether subjects with CC with GER have a distinct lung microbiome and increased inflammation as compared with subjects with CC without GER and to determine whether the microbiome and degree of inflammation is related to the type of GER (acidic versus nonacidic).
- Conditions
- Chronic Cough (CC), Gastroesophageal Reflux (GER)
- Being tested
- Esophago-gastro-duodenoscopy (EGD) with biopsy, Esophageal Impedance Monitoring (EIM)
- 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.
Esophago-gastro-duodenoscopy (EGD) with biopsyProcedure or surgery
Esophageal Impedance Monitoring (EIM)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Case | CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) Receives: Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy; Procedure: Esophageal Impedance Monitoring (EIM) | |
| Control | CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) Receives: Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy; Procedure: Esophageal Impedance Monitoring (EIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
Measured: 2 Years
Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start5 Aug 2014
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cough (CC)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail N Kazachkov, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797756
- Sponsor's protocol ID
- 14-01021
- Status last verified
- Jan 2019
- First submitted
- 8 Jun 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
- ClinicalTrials.gov ID
- NCT02797756
- Acronym / sponsor ID
- 14-01021
- Conditions
- Chronic Cough (CC), Gastroesophageal Reflux (GER)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 13 Jun 2016 (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.
Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. A case-control study design will be used to study whether subjects with CC with GER have a distinct lung microbiome and increased inflammation as compared with subjects with CC without GER and to determine whether the microbiome and degree of inflammation is related to the type of GER (acidic versus nonacidic).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy, Procedure: Esophageal Impedance Monitoring (EIM)CC/GER+ presence of chronic cough and presence of GER evidenced by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) |
| Control | – | Procedure: Esophago-gastro-duodenoscopy (EGD) with biopsy, Procedure: Esophageal Impedance Monitoring (EIM)CC/GER- presence of chronic cough and absence of GER by esophago-gastro-duodenoscopy (EGD) with biopsy and Esophageal Impedance Monitoring (EIM) |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
Key inclusion criteria (1 listed)
- Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks).
Key exclusion criteria (7 listed)
- Antibiotic or steroids (inhaled or systemic) use within the prior one-week. Rationale: Antibacterial drugs and immune-modulators are confounders that may impact the microbiome and inflammation. While longer period free of Antibacterial drugs and immune-modulators would be desired, it would be unethical and it is not the usual standard of care to withdraw treatment for longer periods of time.
- Interstitial Lung Disease or pneumonia on X-ray
- Cystic fibrosis
- Primary ciliary dyskinesia
- Immunodeficiency syndromes
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 |
|---|---|---|
| Esophago-gastro-duodenoscopy (EGD) with biopsy | Procedure or surgery | Case, Control |
| Esophageal Impedance Monitoring (EIM) | Procedure or surgery | Case, Control |
Primary outcome
Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
Time frame: 2 Years
Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group
Time frame: 2 Years
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 29 Jan 2019.
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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.
Mikhail N Kazachkov, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough (CC) and Gastroesophageal Reflux (GER), run by NYU Langone Health at 1 site in United States.
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 7 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 29 Jan 2019. 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 United States. 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. 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?
Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2019.