Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma

Completed

Conditions studied: Asthma, Chronic Rhinosinusitis

In brief

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.

Key facts

Study ID

NCT02548598

Run by

University of California, San Francisco

People needed

9

Starts

2017-01-01

Expected to finish

2021-04-01

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UCSF Airway Clinical Research Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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