Severe Asthma Research Program - Wake Forest University

NCT01750411 | Completed DMC

• 2 other identifiers: IRB000215071U10HL109164-01
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

The mission of SARP is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.

Conditions

Asthma; Severe Persistent Asthma

Keywords

Severe Asthma; SARP

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary function over time

  Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

  36 months

Secondary Outcomes (1)

• Frequency of severe asthma exacerbations

  36 months

Study Arms (1)

Asthma

Severe Asthma Not severe Asthma

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. Given the mission of SARP, a diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. Because there are a number of respiratory disorders that may be confused with asthma or confound asthma assessment, SARP enrollees must meet the all following eligibility criteria as outlined below:

You may qualify if:

• Physician diagnosis of asthma,
• Age 6 years and older
• Evidence of historical reversibility, including either:
• FEV1 bronchodilator reversibility ≥ 12%, or
• Airway hyperresponsiveness reflected by methacholine PC20≤16 mg/mL.

You may not qualify if:

• No primary medical caregiver
• Pregnancy (only if undergoing methacholine challenge or bronchoscopy)
• Current smoking
• 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)
• 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 asthma symptoms, 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

Sponsors & Collaborators

• Wake Forest University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Huang BK, Elicker BM, Henry TS, Kallianos KG, Hahn LD, Tang M, Heng F, McCulloch CE, Bhakta NR, Majumdar S, Choi J, Denlinger LC, Fain SB, Hastie AT, Hoffman EA, Israel E, Jarjour NN, Levy BD, Mauger DT, Sumino K, Wenzel SE, Castro M, Woodruff PG, Fahy JV, Sarp FTNSARP. Persistent mucus plugs in proximal airways are consequential for airflow limitation in asthma. JCI Insight. 2024 Feb 8;9(3):e174124. doi: 10.1172/jci.insight.174124.

  PMID: 38127464 DERIVED

• Dunican EM, Elicker BM, Gierada DS, Nagle SK, Schiebler ML, Newell JD, Raymond WW, Lachowicz-Scroggins ME, Di Maio S, Hoffman EA, Castro M, Fain SB, Jarjour NN, Israel E, Levy BD, Erzurum SC, Wenzel SE, Meyers DA, Bleecker ER, Phillips BR, Mauger DT, Gordon ED, Woodruff PG, Peters MC, Fahy JV; National Heart Lung and Blood Institute (NHLBI) Severe Asthma Research Program (SARP). Mucus plugs in patients with asthma linked to eosinophilia and airflow obstruction. J Clin Invest. 2018 Mar 1;128(3):997-1009. doi: 10.1172/JCI95693. Epub 2018 Feb 5.

  PMID: 29400693 DERIVED

Related Links

• Severe Asthma Research Program Public Website

Biospecimen

Retention: SAMPLES WITH DNA

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

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

• Eugene R Bleecker, MD

  University of Arizona Department of Medicine

  PRINCIPAL INVESTIGATOR

• Deborah A Meyers, PhD

  University of Arizona Department of Medicine

  PRINCIPAL INVESTIGATOR

• Wendy C Moore, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: February 18, 2020
• Study Completion: January 15, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-02

Locations

US (2)