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Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma (AIMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02548598
First received: August 18, 2015
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Asthma
Chronic Rhinosinusitis
Procedure: Endoscopic sinus surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Severity of chronic rhinosinusitis as assessed by the Sino-Nasal Outcome Test-22 [ Time Frame: 6 weeks following endoscopic sinus surgery ]
    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.


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.

Estimated Enrollment: 160
Study Start Date: January 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring 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
This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring 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
This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery.

Detailed Description:

This is a cross-sectional and non-interventional study to investigate mechanisms of disease in patients with asthma who have concomitant chronic sinusitis and/or nasal polyps (upper airway disease). Approximately 160 participants will be enrolled. Patients who are scheduled to undergo inpatient or outpatient endoscopic sinus surgery at the University of California San Francisco for clinical management of their upper airway disease will be invited to participate. Leftover tissues or mucus from the surgery will be collected and processed for research purposes.

This study consists of three study arms, (1) Full Characterization (AIMS-Full), (2) Surgery (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.

Suitable patients, undergoing endoscopic sinus surgery, will be identified and recruited by the study team. Patients will first be asked to participate in the AIMS-Full characterization.

If patients are unable or unwilling to participate in AIMS-Full, they will have the option to take part in the AIMS-OR or AIMS-M arms.

AIMS-OR will consist of the endoscopic sinus surgery with an optional pre-procedure visit during which consent and blood specimens will be obtained and questionnaires will be administered. If the optional pre-procedure visit is not done, consent will be obtained at the surgery visit, and blood will not be collected.

AIMS-M will consist of up to 5 visits. Patients seen in the UCSF Sinus Center clinic may have clearance of sinus mucus as part of routine clinical care; AIMS-M visits will collect these mucus samples that would otherwise be discarded. Sinus mucus obtained at the clinic visit may be used for research purposes if patients have given consent to participate in the AIMS-M arm of the study.

Participants in all three study arms will complete study-specific questionnaires on asthma and allergy history and impairment and provide samples of nasal secretions that are collected as part of routine clinical care and would otherwise be discarded. Those participating in either characterization arm (AIMS-Full or AIMS-OR) will also provide nasal tissues (part of routine surgical procedure); airway epithelial brushings and blood collection (for study purposes only). Those participating in AIMS-Full will also participate in the following study procedures: medical history and physical exam (including vital signs and body anthropometrics), spirometry, methacholine challenge or airway reversibility testing, exhaled nitric oxide, questionnaires (asthma, sinusitis, metabolic health), urine collection, and sputum induction. A participant's time commitment to the study will vary depending on which arm the participant is enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of the UCSF Sinus Center practice of Drs. Andrew Goldberg and Steven Pletcher.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of lung disease other than asthma (e.g., cystic fibrosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
  2. History of hiatal hernia repair
  3. 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)
  4. 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.
  5. Current pregnancy or breastfeeding
  6. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02548598

Contacts
Contact: Kelly McGrath, MS 415-476-8494 kelly.wong@ucsf.edu
Contact: Ariana Baum 415-514-1539 ariana.baum@ucsf.edu

Locations
United States, California
UCSF Airway Clinical Research Center Recruiting
San Francisco, California, United States, 94143
Contact: Kelly McGrath, MS    415-476-8494    kelly.wong@ucsf.edu   
Contact: Ariana Baum    415-514-1539    ariana.baum@ucsf.edu   
Sub-Investigator: Steven Pletcher, MD         
Sub-Investigator: Andrew Goldberg, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John Fahy, MD, MSc University of California, San Francisco
  More Information

Responsible Party: John V. Fahy, Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02548598     History of Changes
Other Study ID Numbers: 14-14945
Study First Received: August 18, 2015
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Asthma
Inflammation
Sinusitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 25, 2017