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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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)