Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program

NCT02103348 | Completed

• 1 other identifier: 14-13242
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. The characterization will include medical history, pulmonary function testing, imaging of the lungs and biospecimen collection.

Conditions

Asthma

Keywords

Severe asthma; Sputum; Mucolysis

Outcome Measures

Primary Outcomes (1)

• Lung function

  Lung function as a measure of asthma severity.

  Cross sectional over 4-6 weeks

Secondary Outcomes (1)

• Inflammatory cellular markers

  Cross sectional over 4-6 weeks

Other Outcomes (1)

• CT Chest

  Cross sectional over 4-6 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL

You may not qualify if:

• 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,
• 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:
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Links

• Airway Clinical Research Center website

Biospecimen

Retention: SAMPLES WITH DNA

Samples of induced sputum and blood for DNA and RNA extraction, plasma, and serum will be banked in the UCSF Airway Tissue Bank.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John V Fahy, M.D. M.SC.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 3, 2014
• Study Start: September 1, 2015
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)