Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma

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.

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