AsthmaSARPNCT01718197
Severe Asthma Research Program (SARP)- San Francisco Clinical Site
An observational study of Asthma, run by University of California, San Francisco at 1 site in United States.
Trial summary
The mission of SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- Type of treatment
- Pill or oral medicine
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 1 Mar 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. SARP will therefore enroll subjects 6 years and older with a physician diagnosis of asthma. The target recruitment goal for each center is 75% adults (age 18 and older) and 25% children age 6-17 years. Within the pediatric age group, an attempt will be made to enroll equal numbers of children 6-11 and 12-17 years of age. Similarly, an attempt will be made to enroll at least 50% females and 30% minorities.
Who may be able to join
- FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL
- An exception will be made for enrollees whose FEV1 is < 50% predicted (<70% in children aged 6 to 17 years), precluding methacholine challenge testing. If bronchodilator reversibility is <12% in these participants, a diagnosis of asthma acceptable to the investigator is sufficient for inclusion in SARP.
Who cannot join
- Pregnancy during the characterization phase,
- Current smoking,
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age,
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways,
- History of premature birth before 35 weeks gestation,
- Unwillingness to receive an intramuscular triamcinolone acetonide injection
Show all 19Show fewer
- Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
- Planning to relocate from the clinical center area before study completion,
- Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record, or
- Currently participating in an investigational drug trial.
- Healthy Controls:
- Inclusion criteria: Healthy subjects between the age of 18y and 65y. At least 3 of the 7 subjects per center should be aged 35y or older.
- History of chronic diseases that affect the lungs.
- A history suggestive of allergic rhinitis, eczema or chronic sinusitis.
- An improvement in FEV1 of more than 12% following 4 puffs of albuterol.
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age, or any smoking within the past year.
- Respiratory tract infection within the past 4 weeks.
- Pregnancy.
- History of premature birth (<35 weeks).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Clinical and Molecular Phenotypes of Severe Asthma
The mission of SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.
Read the detailed description
The mission of the SARP is to improve the understanding of severe asthma to develop better treatments. The SARP will gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease. To this end, the SARP investigators will utilize both mechanistic and evoked phenotype approaches to: 1) characterize developmental molecular, cellular and physiologic phenotypes in children and adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time.
This approach involves a shared longitudinal protocol conducted across all participating centers which includes common information on all SARP participants. Additionally, the SARP-SF has identified mechanistic research questions to be included in the shared longitudinal protocol. This will be explored through additional sample collections of sputum and fluids and biopsied tissue collected by bronchoscopy. Together, these longitudinal and mechanistic approaches will enable prediction of phenotype stability/fluctuation and pharmacologic responses and identification of novel, disease-modifying targets for treatment.
- Conditions
- Asthma
- Keywords
- Severe Asthma, Bronchoscopy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mild-to-Moderate Asthma | Those with mild-to-moderate persistent asthma as defined by the NAEPP EPR-3 guidelines. | |
| Severe Asthma | Major Criteria: (1 required) 1. Treatment with oral corticosteroids for at least 6 of the previous 12 months 2. Treatment with high-dose inhaled corticosteroids (ICS) for at least 10 of the previous 12 months Minor Criteria: (2 required) 1. Daily treatment with an asthma controller medication in addition to ICS, or 2. Asthma symptoms requiring short-acting bronchodilator use on a daily or near daily basis, or 3. Persistent airway obstruction with baseline FEV1 <80% predicted, or 4. ≥ 1 urgent visits for asthma in the previous 12 months, or 5. ≥ 3 systemic corticosteroid bursts in the previous 12 months, or 6. Prompt deterioration with a reduction in oral or inhaled corticosteroid dose, or 7. A near-fatal asthma event (i.e., intubation) in the past | |
| Healthy Controls | Those without asthma or other chronic lung disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function decline
Changes in lung function parameters over time.
Measured: Enrollment, 1 year, 2 years, 3 years
Secondary outcomes (2)
Exacerbation frequency
Number of oral corticosteroid requiring exacerbations of asthma
Measured: Monthly for 3 years
Inflammatory cellular markers
Changes in inflammatory cellular markers in sputum, exhaled breath, and blood.
Measured: Enrollment, 1 year, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completion18 Feb 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John V Fahy, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718197
- Sponsor's protocol ID
- SARP-SF
- Other IDs
- 5U10HL109146-04
- Acronym
- SARP
- Status last verified
- Jul 2025
- First submitted
- 27 Oct 2012
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.
PubMed 38127464Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.
PubMed 29400693
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Phenotypes of Severe Asthma
- ClinicalTrials.gov ID
- NCT01718197
- Acronym / sponsor ID
- SARP / SARP-SF
- Conditions
- Asthma
- Keywords
- Severe Asthma, Bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2012 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 31 Oct 2012 (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.
The mission of SARP is to improve the understanding of severe asthma through integrated study of its clinical and biological features and to evaluate their changes over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.
Detailed description
The mission of the SARP is to improve the understanding of severe asthma to develop better treatments. The SARP will gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease. To this end, the SARP investigators will utilize both mechanistic and evoked phenotype approaches to: 1) characterize developmental molecular, cellular and physiologic phenotypes in children and adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time.
This approach involves a shared longitudinal protocol conducted across all participating centers which includes common information on all SARP participants. Additionally, the SARP-SF has identified mechanistic research questions to be included in the shared longitudinal protocol. This will be explored through additional sample collections of sputum and fluids and biopsied tissue collected by bronchoscopy. Together, these longitudinal and mechanistic approaches will enable prediction of phenotype stability/fluctuation and pharmacologic responses and identification of novel, disease-modifying targets for treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild-to-Moderate Asthma | – | –Those with mild-to-moderate persistent asthma as defined by the NAEPP EPR-3 guidelines. |
| Severe Asthma | – | –Major Criteria: (1 required) 1. Treatment with oral corticosteroids for at least 6 of the previous 12 months 2. Treatment with high-dose inhaled corticosteroids (ICS) for at least 10 of the previous 12 months Minor Criteria: (2 required) 1. Daily treatment with an asthma controller medication in addition to ICS, or 2. Asthma symptoms requiring short-acting bronchodilator use on a daily or near daily basis, or 3. Persistent airway obstruction with baseline FEV1 <80% predicted, or 4. ≥ 1 urgent visits for asthma in the previous 12 months, or 5. ≥ 3 systemic corticosteroid bursts in the previous 12 months, or 6. Prompt deterioration with a reduction in oral or inhaled corticosteroid dose, or 7. A near-fatal asthma event (i.e., intubation) in the past |
| Healthy Controls | – | –Those without asthma or other chronic lung disease. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. SARP will therefore enroll subjects 6 years and older with a physician diagnosis of asthma. The target recruitment goal for each center is 75% adults (age 18 and older) and 25% children age 6-17 years. Within the pediatric age group, an attempt will be made to enroll equal numbers of children 6-11 and 12-17 years of age. Similarly, an attempt will be made to enroll at least 50% females and 30% minorities.
Key inclusion criteria (2 listed)
- FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL
- An exception will be made for enrollees whose FEV1 is < 50% predicted (<70% in children aged 6 to 17 years), precluding methacholine challenge testing. If bronchodilator reversibility is <12% in these participants, a diagnosis of asthma acceptable to the investigator is sufficient for inclusion in SARP.
Key exclusion criteria (19 listed)
- Pregnancy during the characterization phase,
- Current smoking,
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age,
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways,
- History of premature birth before 35 weeks gestation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung function decline
Time frame: Enrollment, 1 year, 2 years, 3 years
Changes in lung function parameters over time.
2 secondary outcomes
Exacerbation frequency
Time frame: Monthly for 3 years
Inflammatory cellular markers
Time frame: Enrollment, 1 year, 2 years, 3 years
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 31 Jul 2025.
- Derived from this study: PubMed 38127464Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.
- Derived from this study: PubMed 29400693Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.
- Severe Asthma Research Program Main WebpageLink provided by the sponsor.
- UCSF Recruitment WebsiteLink provided by the sponsor.
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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 V 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, 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 2 inclusion and 19 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 31 Jul 2025. 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?
Lung function decline (time frame: Enrollment, 1 year, 2 years, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718197, which also lists 2 linked publications.
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 31 Jul 2025.