PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The primary objective of this study is to evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout.

Key facts

Study ID

NCT04129931

Run by

University of North Carolina, Chapel Hill

People needed

950

Starts

2019-12-19

Expected to finish

2025-03-19

Last updated by the study team

2026-04-01

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Started willingness to comply with all study procedures and availability for the duration of the study
• Male or female, age ≥ 12 years
• No change in asthma medications for the past 2 months and use of medium or high dose inhaled corticosteroids (ICS) (defined by Table 1A) + an additional asthma controller/biologic (defined in Tables 1B and 1C). Participants entered into the run-in on medium dose ICS will be switched to high dose ICS. They must meet all entry criteria at the time of randomization including the criteria for uncontrolled asthma as assessed by symptoms during the two weeks prior to the randomization.
• Baseline poor or uncontrolled asthma, defined as meeting at least one of the following:
• Forced Expiratory Volume in one second (FEV1) <80% predicted (for adults ≥18) or FEV1<90% (pediatric participants <18) AND with 12% bronchodilator reversibility
• Poor symptom control - Asthma Control Questionnaire (ACQ-6) Score ≥1.5
• ≥1 exacerbation defined as a documented burst of systemic corticosteroids (>3 days for adults and adolescents or >1 day for adolescents treated with dexamethasone) in prior year for those not receiving chronic oral corticosteriod (OCS) or an increase in >50% of baseline corticosteroid dose for ≥3 days in those receiving chronic OCS.
• For patients on a biologic agent, at least one asthma exacerbation must have occurred at least 2 months after the initiation of the biologic agent. The definition of acceptable documentation for asthma exacerbations can be found in Section 6.5.3.
• Evidence of asthma demonstrated by either bronchodilator reversibility or methacholine responsiveness either during the run-in or by historical evidence of either criterion if testing was performed under the same standards of the PrecISE Network at a PrecISE recruitment center. These criteria are defined as:
• An increase in FEV1 ≥12% (and 200 ml) after up to 8 puffs of albuterol OR
• Positive methacholine defined as provocative concentration causing a 20% decrease in FEV1 (PC20) ≤16 mg/ml, or provocative dose causing a 20% decline in FEV1 (PD20) ≤400 mcg/ml
• Agreement to adhere to Lifestyle Considerations (see Section 5.4) throughout study duration
• Owns a device compatible with the eDiary system used for CompEx, that is, an iOS 11+ device such as iPhone, iPad or iPod, or a smartphone or tablet running on Android 5.0+

You may not qualify if…

• Current participation in an interventional trial (e.g. drugs, diets, etc.)
• Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater)
• Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
• Receiving one or more immune-modulating therapies for diseases other than asthma
• Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®)
• Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy
• Underwent a bronchial thermoplasty within the last two years
• Born before 35 weeks of gestation
• Uncontrolled hypertension, defined as systolic blood pressure >160 mm/Hg, or diastolic blood pressure >100 mm/Hg
• History of malignancy except non-melanoma skin cancer within the last five years
• History of smoking
• If <30 years old: Smoked for ≥5 pack-years*
• Can still be enrolled if <30, smoked <5 5 pack years and none in past year, and normal (negative) urine cotinine
• If 30-39 years old: Smoked for ≥10 pack years
• Can still be enrolled if ≥30, smoked <10 pack years and none in past year, provided participant demonstrates a normal (negative) urine cotinine
• If ≥40 years old: Smoked ≥15 pack years
• Can still be enrolled if ≥40 years old, smoked <15 pack years and none in the last year, provided participant demonstrates normal (negative) urine cotinine. Patients with a smoking history of ≥10 to <15 pack years will also need to demonstrate a normal Diffusing Capacity for Carbon Monoxide (DLCO) (>70% predicted) * Smoking equivalent pack years. One pack of cigarettes a day for 1 year is equivalent to:
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• 1 cigar or pipe per day for 1 year
• Smoked hookah or shisha =1 session per day for 1 year
• Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year
• 1 use of marijuana per day for 1 year
• Active use of any inhalant >1 time per month in the past year
• Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods >1 time per month in the past year
• Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc.

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• University of Arizona Tucson — Tucson, Arizona, United States
• University of California Davis — Sacramento, California, United States
• University of California San Diego: Airway Research & Clinical Trials Center — San Diego, California, United States
• University of California San Diego: La Jolla Altman Clinical Translation Research Institute — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Colorado Denver — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of South Florida — Tampa, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• Northwestern Universtiy — Chicago, Illinois, United States
• Rush University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Kansas — Kansas City, Kansas, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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