Project 2 Airway Potential Hydrogen (pH) in Asthma
United States74 participantsStarted 2018-11-01
Plain-language summary
This study is testing a non invasive way to measure airway pH in individuals with Asthma and Cystic Fibrosis using a new inhaled drug. The airway pH will help health care providers in creating tailored treatment plans for individuals suffering from these specific conditions.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Asthma diagnosis established during at least 3 months of evaluation and care by an asthma specialist (pulmonologist or allergist).
✓. Adult male or female age ≥ 18 and ≤ 50 years at the time of enrollment
✓. Forced expiratory volume in 1 second (FEV1) bronchodilator reversibility \> 12% or methacholine FEV1 by 20% of baseline (PC20) \< 16 mg/ml (historical methacholine data from previous NIH trial including Severe Asthma Research Program (SARP) or Asthma Network (AsthmaNet) will be allowed).
✓. If FEV1 is \<50% predicted, precluding methacholine challenge testing, investigator acceptance of the diagnosis of asthma is acceptable
✓. Treatment with high-dose inhaled corticosteroids (\> 880 mcg fluticasone or highest marketed equivalent/day) along with a second controller or systemic corticosteroids for at least 3 months prior to enrollment and for at least 6 of the last 12 months.
✓. Lack of asthma control despite this treatment evidenced by any one of the following:
✓. Asthma Control Questionnaire (ACQ) \> 1.5 or Asthma Control Test (ACT) \< 20
✓. \>2 bursts of systemic corticosteroids (3 days or more) in the previous 12 months
Exclusion criteria
✕. \> 5 pack year smoking history
✕. Body mass index (BMI) greater than 45
✕. Unable to perform repeatable consistent efforts in pulmonary function testing
What they're measuring
1
Changes in Fractional Exhaled Nitric Oxide (FeNO) levels
Timeframe: Baseline, every 15 minutes after administration of glycine buffer for 60 minutes
2
Frequency of shared phenotypic features among participants with low airway pH compared to those with low exhaled breath condensate (EBC) pH
✕. Individuals with prior diagnosis of vocal cord dysfunction or an anatomic anomaly that would increase the risks associated with the bronchoscopy procedure
✕. Prior diagnosis of any chronic lung disease that in the investigator's opinion would make them unsuitable for study participation
✕. History of premature birth before 35 weeks gestation
✕. Planning to relocate away from the clinical center (Cleveland, Ohio) area before study completion
✕. Lack of reliable communications channel (hard-wire phone, cell phone, email for follow-up contacts after bronchoscopy)