NCT03617718

Project 2 Airway Potential Hydrogen (pH) in Asthma

Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Asthma can affect patients in different ways. Some of the differences in how severe asthma is or how well patients respond to asthma medicines are due to differences in the biology of the airways or breathing tubes. The pH of the airway, which is a measure of the balance between acids and bases in our airways, is one example of how differences in biology can affect asthma and other lung diseases. Airway pH can be measured during a procedure called a bronchoscopy, in which a camera is inserted into the airways or breathing tubes. The lower the pH, the more acid is present. People with lower airway pHs, or more acid present in their airways/breathing tubes, tend to have more trouble with their asthma. The pH value or acid level in the airway plays a role in respiratory function (breathing) and preventing inflammation (swelling) in the respiratory tract (throat, airways, and lungs). Studies have found that in individuals with asthma, Cystic Fibrosis (CF) and other pulmonary disorders, a lower pH value is present in the airway when compared to healthy individuals. Studies have also found that patients with asthma have a lower airway pH during asthma flares, and may affect how well some breathing medicines work. If we can better identify the changes in the airways or breathing pipes in patients with asthma and CF, we may be able to help patients make better choices about the medicines or treatments that are most likely to work best for each patient. Right now the only way to measure airway pH is with a bronchoscopy procedure. During a bronchoscopy, a scope with a camera is inserted into the breathing tubes, often under sedation in a special procedure area. This research study is being done to test if we can measure how acidic the airway is in a simple and non-invasive test that can be done in a doctor's office. This non-invasive diagnostic test, called a Glycine Buffer Challenge test, may be able to identify which asthma and CF patients have low airway pH levels. We are also studying the phenotypes (observable traits) in asthma and CF patients with decreased airway pH values. If this research study is successful, in the future (after this research study is done) we may be able to offer better ways to treat patients with low airway pH. The Glycine Buffer Challenge test includes giving an investigational drug to breathe in (inhale). The investigational drug is the Glycine Buffer. "Investigational" means the drug is not approved by any regulatory agencies including the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. The research is registered with the FDA, but again the Glycine Buffer treatment in this study administered (during the Glycine Buffer challenge testing) is not an approved treatment or diagnostic test for asthma. The study will enroll a total of 75 volunteers; 50 volunteers with severe asthma, 15 volunteers with cystic fibrosis, and 10 healthy volunteers.

Conditions

• Cystic Fibrosis
• Asthma
• Severe Persistent Asthma
• Healthy

Interventions

Type	Name	Description
DRUG	Glycine Buffer	Subjects will be asked to perform an Inhaled Glycine Buffer followed by a series of Pulmonary Function Tests (PFTs) and then a research bronchoscopy will happen at visit 3.

Timeline

• Start date: 2018-11-01
• Primary completion: 2025-07-16
• Completion: 2025-07-16
• First posted: 2018-08-06
• Last updated: 2025-08-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study