Severe Asthma Research Program (SARP)- San Francisco Clinical Site

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01718197
First received: October 27, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Severe Asthma Research Program

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Lung function decline [ Time Frame: Enrollment, 1 year, 2 years, 3 years ] [ Designated as safety issue: Yes ]
    Changes in lung function parameters over time.


Secondary Outcome Measures:
  • Exacerbation frequency [ Time Frame: Monthly for 3 years ] [ Designated as safety issue: Yes ]
    Number of oral corticosteroid requiring exacerbations of asthma

  • Inflammatory cellular markers [ Time Frame: Enrollment, 1 year, 2 years, 3 years ] [ Designated as safety issue: Yes ]
    Changes in inflammatory cellular markers in sputum, exhaled breath, and blood.


Biospecimen Retention:   Samples With DNA

Blood: CBC/Diff, Total IgE, Serum, Plasma, DNA, RNA Urine EBC Sputum: Supernatant, Cell Pellet Bronchoscopy: BAL, Bronchial Brushings, Bronchial Biopsy


Estimated Enrollment: 749
Study Start Date: November 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 continuous or near-continuous 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 corticosteroids (i.e., long-acting beta-agonists, montelukast, theophylline), 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.

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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. 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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Exclusion criteria

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718197

Contacts
Contact: Jennifer Soh 415-476-5040 jennifer.soh@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: John V Fahy, MD, MSc         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John V Fahy, MD, MSc University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01718197     History of Changes
Other Study ID Numbers: SARP-SF
Study First Received: October 27, 2012
Last Updated: March 11, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of California, San Francisco:
Severe Asthma
Bronchoscopy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014