Chronic Cough (CC) Clinical Trial
Official title:
Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
| NCT number | NCT02797756 |
| Other study ID # | 14-01021 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 5, 2014 |
| Est. completion date | December 12, 2018 |
| Verified date | January 2019 |
| Source | New York University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | December 12, 2018 |
| Est. primary completion date | December 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 24 Years |
| Eligibility |
Inclusion Criteria: - Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (>4weeks). Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York University School of Medicine | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| New York University School of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group | 2 Years | ||
| Primary | Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group | 2 Years |