AsthmaAIMSNCT02548598
Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma
An observational study of Asthma and Chronic Rhinosinusitis, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Rhinosinusitis
- What is being tested?
- Endoscopic sinus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the UCSF Sinus Center practice of Drs. Andrew Goldberg and Steven Pletcher.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Asthma, Chronic Rhinosinusitis
- Being tested
- Endoscopic sinus surgery
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sinus surgeryProcedure or surgery
This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery.
| Study group | Role | What they receive |
|---|---|---|
| AIMS-Full Characterization | Participants in this group undergo characterization at the UCSF Airway Clinical Research Center 6 weeks following their scheduled sinus surgery. Receives: 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. Receives: 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. Receives: Procedure: Endoscopic sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks following endoscopic sinus surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJan 2017
- Primary completionSep 2017
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548598
- Sponsor's protocol ID
- 14-14945
- Acronym
- AIMS
- Status last verified
- Apr 2021
- First submitted
- 18 Aug 2015
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma
- ClinicalTrials.gov ID
- NCT02548598
- Acronym / sponsor ID
- AIMS / 14-14945
- Conditions
- Asthma, Chronic Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2017 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIMS-Full Characterization | – | Procedure: Endoscopic sinus surgeryParticipants in this group undergo characterization at the UCSF Airway Clinical Research Center 6 weeks following their scheduled sinus surgery. |
| AIMS-OR | – | Procedure: Endoscopic sinus surgeryParticipants 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. |
| AIMS-M | – | Procedure: Endoscopic sinus surgeryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the UCSF Sinus Center practice of Drs. Andrew Goldberg and Steven Pletcher.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic sinus surgeryThis is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery. | Procedure or surgery | AIMS-Full Characterization, AIMS-M, AIMS-OR |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fahy, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Rhinosinusitis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of chronic rhinosinusitis as assessed by the Sino-Nasal Outcome Test-22 (time frame: 6 weeks following endoscopic sinus surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.