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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548598
Recruitment Status : Active, not recruiting
First Posted : September 14, 2015
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco

Tracking Information
First Submitted Date August 18, 2015
First Posted Date September 14, 2015
Last Update Posted Date December 17, 2019
Study Start Date January 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma
Official Title Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Mucus collected from the airway, induced sputum, brushings from the airway epithelium, mucus collected from the nasal passages, and blood.
Sampling Method Non-Probability Sample
Study Population Patients of the UCSF Sinus Center practice of Drs. Andrew Goldberg and Steven Pletcher.
Condition
  • Asthma
  • Chronic Rhinosinusitis
Intervention Procedure: Endoscopic sinus surgery
This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery.
Study Groups/Cohorts
  • AIMS-Full Characterization
    Participants in this group undergo characterization at the UCSF Airway Clinical Research Center 6 weeks following their scheduled sinus surgery.
    Intervention: 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.
    Intervention: 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.
    Intervention: Procedure: Endoscopic sinus surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 10, 2015)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02548598
Other Study ID Numbers 14-14945
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John V. Fahy, University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: John Fahy, MD, MSc University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2019