AsthmaCAESARNCT02103348
Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program
An observational study of Asthma, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study is designed to characterize subjects in terms of their sputum phenotype. The purpose of this study is to learn more about the impact of having abnormally elastic sputum on asthma severity by comparing subjects with severe as well as mild/moderate asthma to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 26 Feb 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. CAESAR will therefore enroll subjects between 18 and 65 years with a physician diagnosis of asthma as well as a group of healthy subjects. The target recruitment goal for UCSF is 50 adults with asthma and 25 healthy controls (age 18 and older). Within the asthma group, an attempt will be made to enroll 60% of subjects with severe with the rest of the subjects mild to moderate asthma.Within the cohort, an attempt will be made to enroll at least 50% females and 10% 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 CAESAR.
Who cannot join
- Pregnancy,
- 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,
- Planning to relocate from the clinical center area before study completion,
Show all 17Show fewer
- 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
This study is designed to characterize subjects in terms of their sputum phenotype. The purpose of this study is to learn more about the impact of having abnormally elastic sputum on asthma severity by comparing subjects with severe as well as mild/moderate asthma to healthy controls. The characterization will include medical history, pulmonary function testing, imaging of the lungs and biospecimen collection.
Read the detailed description
Asthma is a heterogeneous disease characterized by airway hyperreactivity and chronic airway inflammation. Published literature from the last few years has shown that asthma does not behave like a single disease but is more of a syndrome with vast heterogeneity in pathogenesis, severity, and treatment response. Various clinical phenotypes and endotypes have been described that advance our understanding of these differences and the mechanisms underlying them. We propose there is a subgroup of asthmatic patients that have sputum with abnormal biophysical properties. Healthy airway mucus is composed of a lightly cross-linked gel that is easily transported by the mucociliary apparatus, coughed and expectorated or swallowed. Pathologic mucus has, in contrast, abnormally high elasticity. This is due to a more cross linked structure which gives the sputum the properties of solid and makes sputum difficult to mobilize. Increased sputum elasticity makes expectoration of sputum more difficult and leads to airflow obstruction. Pathologic mucus contributes to airflow obstruction and airway infection in multiple lung diseases, including asthma. Mucus plugs are a particular problem in asthmatic patients with allergic bronchopulmonary aspergillosis (ABPA)The identification of phenotype of severe asthma with pathologic mucus contributing to disease severity may change how we think about severe asthma, moving towards therapies targeting mucus clearance such as in other conditions such as cystic fibrosis. Pathologic mucus in severe asthma is characterized by cellular inflammation, high concentrations of mucins and DNA polymers. Knowledge of specific cellular and biochemical constituents of pathologic mucus in severe asthma can guide targeted mucolytic treatment with n-acetylcysteine, rhDNAse, or novel mucolytic agents.
As part of the Severe Asthma Research Program (SARP), UCSF is in a unique position to recruit a large number of severe asthmatic subjects within which we expect a portion will demonstrate high sputum elasticity. We will also through CAESAR recruit additional subjects with moderate to severe airflow obstruction. We will perform rheological measurement on all subjects that are recruited to our site and from this identify a group of asthmatic cases that have an elastic modulus of ≥1 or <1 and compare properties of sputum from these subjects to healthy controls.
- Conditions
- Asthma
- Keywords
- Severe asthma, Sputum, Mucolysis
- 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 for at least 10 of the previous 12 months Minor Criteria: (2 required) 1. Daily treatment with an asthma controller medication in addition to inhaled, or 2. Asthma symptoms requiring short-acting bronchodilator use on a daily or near daily basis (defined as at least 5 of 7 days), 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
Lung function as a measure of asthma severity.
Measured: Cross sectional over 4-6 weeks
Secondary outcomes (1)
Inflammatory cellular markers
Changes in inflammatory cellular markers in sputum and blood. We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.
Measured: Cross sectional over 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startSep 2015
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John V Fahy, M.D. M.SC., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103348
- Sponsor's protocol ID
- 14-13242
- Acronym
- CAESAR
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2014
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program
- ClinicalTrials.gov ID
- NCT02103348
- Acronym / sponsor ID
- CAESAR / 14-13242
- Conditions
- Asthma
- Keywords
- Severe asthma, Sputum, Mucolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 3 Apr 2014 (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 study is designed to characterize subjects in terms of their sputum phenotype. The purpose of this study is to learn more about the impact of having abnormally elastic sputum on asthma severity by comparing subjects with severe as well as mild/moderate asthma to healthy controls. The characterization will include medical history, pulmonary function testing, imaging of the lungs and biospecimen collection.
Detailed description
Asthma is a heterogeneous disease characterized by airway hyperreactivity and chronic airway inflammation. Published literature from the last few years has shown that asthma does not behave like a single disease but is more of a syndrome with vast heterogeneity in pathogenesis, severity, and treatment response. Various clinical phenotypes and endotypes have been described that advance our understanding of these differences and the mechanisms underlying them. We propose there is a subgroup of asthmatic patients that have sputum with abnormal biophysical properties. Healthy airway mucus is composed of a lightly cross-linked gel that is easily transported by the mucociliary apparatus, coughed and expectorated or swallowed. Pathologic mucus has, in contrast, abnormally high elasticity. This is due to a more cross linked structure which gives the sputum the properties of solid and makes sputum difficult to mobilize. Increased sputum elasticity makes expectoration of sputum more difficult and leads to airflow obstruction. Pathologic mucus contributes to airflow obstruction and airway infection in multiple lung diseases, including asthma. Mucus plugs are a particular problem in asthmatic patients with allergic bronchopulmonary aspergillosis (ABPA)The identification of phenotype of severe asthma with pathologic mucus contributing to disease severity may change how we think about severe asthma, moving towards therapies targeting mucus clearance such as in other conditions such as cystic fibrosis. Pathologic mucus in severe asthma is characterized by cellular inflammation, high concentrations of mucins and DNA polymers. Knowledge of specific cellular and biochemical constituents of pathologic mucus in severe asthma can guide targeted mucolytic treatment with n-acetylcysteine, rhDNAse, or novel mucolytic agents.
As part of the Severe Asthma Research Program (SARP), UCSF is in a unique position to recruit a large number of severe asthmatic subjects within which we expect a portion will demonstrate high sputum elasticity. We will also through CAESAR recruit additional subjects with moderate to severe airflow obstruction. We will perform rheological measurement on all subjects that are recruited to our site and from this identify a group of asthmatic cases that have an elastic modulus of ≥1 or <1 and compare properties of sputum from these subjects to healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- 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 for at least 10 of the previous 12 months Minor Criteria: (2 required) 1. Daily treatment with an asthma controller medication in addition to inhaled, or 2. Asthma symptoms requiring short-acting bronchodilator use on a daily or near daily basis (defined as at least 5 of 7 days), 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
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. CAESAR will therefore enroll subjects between 18 and 65 years with a physician diagnosis of asthma as well as a group of healthy subjects. The target recruitment goal for UCSF is 50 adults with asthma and 25 healthy controls (age 18 and older). Within the asthma group, an attempt will be made to enroll 60% of subjects with severe with the rest of the subjects mild to moderate asthma.Within the cohort, an attempt will be made to enroll at least 50% females and 10% 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 CAESAR.
Key exclusion criteria (17 listed)
- Pregnancy,
- 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
Time frame: Cross sectional over 4-6 weeks
Lung function as a measure of asthma severity.
1 secondary outcome
Inflammatory cellular markers
Time frame: Cross sectional over 4-6 weeks
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.
- Airway Clinical Research Center websiteLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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, M.D. M.SC. 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 17 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 (time frame: Cross sectional over 4-6 weeks). 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 31 Jul 2025.