Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma

NCT02548598 | Completed

• 1 other identifier: 14-14945
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cross-sectional, non-interventional study, consisting of three study arms, (1) Full Characterization (AIMS-Full), (2) Surgery Arm (AIMS-OR), and (3) Mucus Collection (AIMS-M). Participants will be recruited and enrolled in either AIMS-Full or AIMS-OR (based on participant availability). Participants who complete the initial characterization study (either AIMS-Full or AIMS-OR), may also go on to participate in the AIMS-M arm, which focuses mainly on sample collection. Participants who choose not to participate in either characterization arm are able to enroll directly into AIMS-M for sample collection only.

Conditions

Asthma; Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Severity of chronic rhinosinusitis as assessed by the Sino-Nasal Outcome Test-22

  This study enrolls participants with and without asthma with concomitant chronic rhinosinusitis (CRS). Investigators aim to study severity of CRS among the two groups following endoscopic sinus surgery. Severity of CRS will be judged using the Sino-Nasal Outcome Test-22, a paper-based, validated questionnaire.

  6 weeks following endoscopic sinus surgery

Study Arms (3)

AIMS-Full Characterization

Participants in this group undergo characterization at the UCSF Airway Clinical Research Center 6 weeks following their scheduled sinus surgery.

Procedure: Endoscopic sinus surgery

AIMS-OR

Participants in this group complete limited questionnaires and provide biological samples that are collected during their scheduled sinus surgery. No further characterization in done in this group.

Procedure: Endoscopic sinus surgery

AIMS-M

Participants returning to UCSF Sinus Center clinic following sinus surgery who have nasal secretions that are removed by a study clinician will provide samples at these clinic visits.

Procedure: Endoscopic sinus surgery

Interventions

Endoscopic sinus surgery PROCEDURE

This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery.

AIMS-Full Characterization; AIMS-M; AIMS-OR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the UCSF Sinus Center practice of Drs. Andrew Goldberg and Steven Pletcher.

You may qualify if:

• Male or female ≥18 years of age at Visit 0.
• Diagnosis of bilateral chronic sinusitis with a minimum Lund-MacKay CT score of 6 and/or diagnosis of nasal polyps
• Half of the patients need to have a history of asthma

You may not qualify if:

• History of lung disease other than asthma (e.g., cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
• History of hiatal hernia repair
• History of cigarette and/or marijuana smoking (\>10 total pack years, smokes \>5 cigarettes per month, smoking within 2 weeks of study participation, marijuana use within 1 month of study participation)
• If a participant has had an upper respiratory tract infection and/or an exacerbation of his/her asthma within 4-6 weeks of the characterization visit, this visit will be rescheduled to 4 weeks after recovery.
• Current pregnancy or breastfeeding
• History of medical disease, which, in the opinion of the investigator, may put the participant at extra risk from study-related procedures or because disease may influence the results of the study

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mucus collected from the airway, induced sputum, brushings from the airway epithelium, mucus collected from the nasal passages, and blood.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John Fahy, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: September 14, 2015
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: April 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (1)