Project 2 Airway Potential Hydrogen (pH) in Asthma
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|ClinicalTrials.gov Identifier: NCT03617718|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Asthma Severe Persistent Asthma Healthy||Drug: Glycine Buffer||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will go through the same study procedures.|
|Masking:||None (Open Label)|
|Official Title:||Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Glycine Buffer
All participants will be asked to inhale a glycine buffer at visit 2 prior to the research bronchoscopy that is performed at visit 3.
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.
- Changes in Fractional Exhaled Nitric Oxide (FeNO) levels [ Time Frame: Baseline, 3 months ]Airway pH and FeNO measurements will be compared among the three different participant groups (Cystic Fibrosis, Severa Asthma and Healthy Volunteers).
- Frequency of shared phenotypic features among participants with low airway pH compared to those with low exhaled breath condensate (EBC) pH [ Time Frame: Baseline, 3 months ]The number of times that the phenotypic features of low EBC pH ( high BMI (>30), low methacholine PC20 (<5), age, and bronchoalveolar lavage neutrophils) are also shared with participants that are found to have a low airway pH.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617718
|Contact: Kristie R Ross, MDfirstname.lastname@example.org|
|United States, Ohio|
|University Hospitals Cleveland Medical Center - Asthma Research Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Kristie R Ross, MD 216-286-6566 PACTStudy@uhhospitals.org|
|Principal Investigator:||Kristie R Ross||University Hospitals Cleveland Medical Center|