Severe Asthma Research Program

Active, not recruiting

• Conditions: Asthma

• Registration Number: NCT01606826
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

The mission of the 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 investigators have each identified mechanistic research questions to be included in the shared longitudinal protocol. 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 Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Physician diagnosis of asthma,

2. Age 6 years and older

3. Evidence of historical reversibility, including either:

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

Exclusion Criteria

1. Pregnancy during the characterization phase,
2. Current smoking,
3. Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year),
4. 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,
5. History of premature birth before 35 weeks gestation,
6. Unwillingness to receive an intramuscular triamcinolone acetonide injection,
7. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
8. Planning to relocate from the clinical center area before study completion,
9. 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
10. Currently participating in an investigational drug trial for asthma therapies.

Healthy Controls:

Inclusion criteria: Healthy subjects between the age of 18 and 65 years. Exclusion criteria

1. History of chronic diseases that affect the lungs,
2. A history suggestive of allergic rhinitis, eczema or chronic sinusitis,
3. An improvement in FEV1 of more than 12% following 4 puffs of albuterol,
4. 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,
5. Respiratory tract infection within the past 4 weeks,
6. Pregnancy,
7. History of premature birth (<35 weeks).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary function test results	36 months after enrollment	Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

Secondary Outcome Measures

Name	Time	Method
Frequency of severe asthma exacerbations	36 months after enrollment

Trial Locations

Locations (8)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital, Boston; 🇺🇸 Boston, Massachusetts, United States