Severe Asthma Research Program

Asthma Clinical Trial

— SARP  

Official title:

Severe Asthma Research Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01606826
• Other study ID #: SARP003
• Secondary ID: 1U10HL109086
• Status: Active, not recruiting
• Start date: October 2012
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01761058

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Asthmatic Patients:

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).

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Children's Hospital, Boston	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Washington University	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test results	Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).	36 months after enrollment
Secondary	Frequency of severe asthma exacerbations		36 months after enrollment

External Links

•   Severe Asthma Research Program (SARP) Public Website