PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study (NCT04129931) | Clinical Trial Compass
CompletedPhase 2
PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
United States950 participantsStarted 2019-12-19
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Current participation in an interventional trial (e.g. drugs, diets, etc.)
What they're measuring
1
Forced Expiratory Volume in One Second (FEV1) Percent Predicted
Timeframe: Measured at 16 weeks after the start of treatment.
2
The Juniper Asthma Control Questionnaire (ACQ-6)
Timeframe: Measured at 16 weeks after the start of treatment.
. 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