Clinical trial · Observational
Severe Asthma Research Program
NCT01606826CI-TRIAL-00122163SARPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Asthmatics
- description
- Subjects with active asthma.
- label
- Healthy Controls
- description
- Subjects without any known pulmonary disease.
Primary outcomes (1)
- measure
- Pulmonary function test results
- timeFrame
- 36 months after enrollment
- description
- Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Secondary outcomes (1)
- measure
- Frequency of severe asthma exacerbations
- timeFrame
- 36 months after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
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).
References
Publications (7)
- DERIVEDHuang 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
- DERIVEDCoverstone AM, Boomer JS, Lew D, Bacharier LB, Castro M; Severe Asthma Research Program (SARP) Investigators. Type 2 inflammation in the sputum of adolescents with asthma. Ann Allergy Asthma Immunol. 2021 Mar;126(3):297-299. doi: 10.1016/j.anai.2020.11.018. Epub 2020 Dec 2. No abstract available. PMID 33276117
- DERIVEDRoss KR, Gupta R, DeBoer MD, Zein J, Phillips BR, Mauger DT, Li C, Myers RE, Phipatanakul W, Fitzpatrick AM, Ly NP, Bacharier LB, Jackson DJ, Celedon JC, Larkin A, Israel E, Levy B, Fahy JV, Castro M, Bleecker ER, Meyers D, Moore WC, Wenzel SE, Jarjour NN, Erzurum SC, Teague WG, Gaston B. Severe asthma during childhood and adolescence: A longitudinal study. J Allergy Clin Immunol. 2020 Jan;145(1):140-146.e9. doi: 10.1016/j.jaci.2019.09.030. Epub 2019 Oct 14. PMID 31622688
- DERIVEDFitzpatrick AM, Szefler SJ, Mauger DT, Phillips BR, Denlinger LC, Moore WC, Sorkness RL, Wenzel SE, Gergen PJ, Bleecker ER, Castro M, Erzurum SC, Fahy JV, Gaston BM, Israel E, Levy BD, Meyers DA, Teague WG, Bacharier LB, Ly NP, Phipatanakul W, Ross KR, Zein J, Jarjour NN. Development and initial validation of the Asthma Severity Scoring System (ASSESS). J Allergy Clin Immunol. 2020 Jan;145(1):127-139. doi: 10.1016/j.jaci.2019.09.018. Epub 2019 Oct 8. PMID 31604088
- DERIVEDDunican 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.