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Glycine Buffer for Airway pH Measurement in Asthma
Phase 1 & 2
Recruiting
Led By Kristie R Ross, MD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with Severe Asthma
Mild to moderate obstructive lung disease with 45%< FEV1 < 80% predicted (with low FEV1/FVC) prior to bronchodilator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study Summary
This trial is testing a new way to measure airway pH in people with asthma and cystic fibrosis, using a new inhaled drug. The airway pH will help doctors tailor treatment plans for these conditions.
Who is the study for?
Adults aged 18-50 with Asthma or Cystic Fibrosis can join this trial. For asthma, they need a history of severe symptoms and poor control despite treatment. People with cystic fibrosis must have mild lung disease and meet diagnostic criteria. Healthy volunteers without chronic lung diseases or severe allergies are also eligible. Exclusions include certain medications, recent exacerbations, other chronic illnesses, pregnancy, smoking history over 5 pack years, and inability to perform consistent pulmonary tests.Check my eligibility
What is being tested?
The trial is testing an inhaled Glycine Buffer to measure airway pH non-invasively in individuals with Asthma and Cystic Fibrosis. The goal is to help healthcare providers create personalized treatment plans based on the airway pH levels measured during the study procedures.See study design
What are the potential side effects?
Since this is a non-invasive method focusing on measuring airway pH using an inhaled substance (Glycine Buffer), side effects may be minimal but could potentially include throat irritation or coughing during inhalation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe asthma.
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My lung function is reduced but not severely (45%-80% of what's expected).
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I am between 18 and 50 years old.
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I've been on high-dose inhaled or systemic steroids for my condition for at least 3 months.
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I've had more than 2 rounds of corticosteroids for 3+ days in the last year.
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I have been hospitalized or in the ICU for asthma more than once in the last year.
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I have never had asthma, COPD, or any chronic lung disease.
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I have Cystic Fibrosis.
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I am between 18 and 50 years old.
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I have been diagnosed with cystic fibrosis based on symptoms and lab tests.
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I weigh more than 50 kg.
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I am between 18 and 50 years old.
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I have two known mutations in my CFTR gene causing cystic fibrosis.
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My lung function is slightly reduced but above 70% of what's expected for my age, height, and gender.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Fractional Exhaled Nitric Oxide (FeNO) levels
Frequency of shared phenotypic features among participants with low airway pH compared to those with low exhaled breath condensate (EBC) pH
Large airway pH as measured by bronchoscopy
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Healthy ControlExperimental Treatment1 Intervention
All Healthy Control participants will undergo screening, baseline characterization, a non-invasive challenge test with inhaled alkaline glycine buffer, followed by repeated measurements of airway function and inflammation, and a research bronchoscopy.
Group II: Cystic FibrosisExperimental Treatment1 Intervention
All Cystic Fibrosis participants will undergo screening, baseline characterization, a non-invasive challenge test with inhaled alkaline glycine buffer, followed by repeated measurements of airway function and inflammation, and a research bronchoscopy.
Group III: AsthmaExperimental Treatment1 Intervention
All Asthma participants will undergo screening, baseline characterization, a non-invasive challenge test with inhaled alkaline glycine buffer, followed by repeated measurements of airway function and inflammation, and a research bronchoscopy.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,802 Total Patients Enrolled
58 Trials studying Asthma
8,233 Patients Enrolled for Asthma
Case Western Reserve UniversityLead Sponsor
299 Previous Clinical Trials
246,508 Total Patients Enrolled
6 Trials studying Asthma
4,806 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,580 Total Patients Enrolled
276 Trials studying Asthma
112,477 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had an asthma attack in the last 4 weeks.Your blood pressure is too high or too low at the time of screening.I haven't started any new long-term treatments in the last 4 weeks.My health has been stable, and my lung function hasn't significantly changed in the last 4 weeks.I have taken Kalydeco within the last 3 months.People who are not experiencing any health issues.You have smoked the equivalent of 5 packs of cigarettes per year for more than one year.You have a very high body mass index (BMI).You were born before 35 weeks of pregnancy.I have diabetes (type 1 or type 2), including CF-related diabetes.My creatinine level is not above 1.8 mg/dl.You have other ongoing health conditions like heart, lung, kidney, liver, or brain problems, or any other serious health issues that the screening doctor thinks might make it unsafe for you to be in the study.I haven't taken antibiotics for an infection in the last 2 weeks.I am currently taking blood thinners like warfarin or heparin.I am currently being treated for a non-tuberculous mycobacterial infection.Your blood takes longer than normal to clot.My liver enzymes are high, or I have a history of liver issues.I don't have any health issues that could make this study riskier for me.I've had more than 3 flare-ups of my condition in the last 6 months.My condition does not meet the specific exclusions for cystic fibrosis.You have tested positive for Burkholderia cepacia complex in your sputum in the past year.You are currently waiting for a lung or other organ transplant.I have not had significant coughing up of blood in the past year.I have severe asthma.My lung function improves significantly with medication or worsens with certain tests.If your lung function is very low, making it difficult to do certain breathing tests, the doctor can use other methods to confirm if you have asthma.Your asthma is not well controlled, as indicated by specific questionnaire scores.My lung function is reduced but not severely (45%-80% of what's expected).You don't have a history of serious allergies that needed special treatment.Your sweat chloride level is 60 m/Eq/L or higher on a sweat test.I have a condition or throat issue that makes bronchoscopy risky.I do not have a chronic lung disease that would prevent me from joining the study.I am allergic to anesthesia used in bronchoscopy.I am currently taking beta-blockers, antidepressants, meperidine, or nitrates.I have been diagnosed with asthma by a specialist for over 3 months.I am between 18 and 50 years old.I've been on high-dose inhaled or systemic steroids for my condition for at least 3 months.I've had more than 2 rounds of corticosteroids for 3+ days in the last year.I have been hospitalized or in the ICU for asthma more than once in the last year.I have never had asthma, COPD, or any chronic lung disease.I have Cystic Fibrosis.I am between 18 and 50 years old.I have been diagnosed with cystic fibrosis based on symptoms and lab tests.I weigh more than 50 kg.I was put on a breathing machine for asthma in the last year.I have a blood disorder that affects clotting or oxygen delivery.I have a history of high blood pressure in the lungs.My lung function is less than 55% of what is expected.I am between 18 and 50 years old.I have two known mutations in my CFTR gene causing cystic fibrosis.I cannot do consistent breathing tests.I need extra oxygen or my oxygen levels are often below 92%.I am severely malnourished.My lung function is slightly reduced but above 70% of what's expected for my age, height, and gender.I have not had a collapsed lung in the past 2 years.I do not have severe asthma.My asthma is not well-controlled despite treatment.I haven't started or changed my asthma medication in the last 2 months.People who do not smoke.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Control
- Group 2: Cystic Fibrosis
- Group 3: Asthma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other scientific investigations that have used Glycine Buffer?
"The year 2007 saw the first clinical trial testing Glycine Buffer at Surgical Intensive Care Unit Regional Hospital Jessa. In the 14 years since, there have been 22 completed trials with 3 more active studies. Many of these latter investigations are based out of Indianapolis, Indiana."
Answered by AI
What does Glycine Buffer typically help alleviate?
"Glycine Buffer can provide relief for patients experiencing endoscopy, surgery recovery, or infection."
Answered by AI
Could I potentially enroll as a subject in this experiment?
"This study is for patients with cystic fibrosis who are aged 18 to 50. They will be one of around 75 people taking part in the trial."
Answered by AI
Are people with the required qualifications still able to participate in this research?
"This study, as reported on clinicaltrials.gov, is actively seeking patients. The trial was first posted on November 1st 2018 and was last edited on February 24th 2022."
Answered by AI
How competitive is this clinical trial in terms of patient selection?
"That is correct. According to the information available on clinicaltrials.gov, this study is still seeking participants. The listing was first posted on November 1st, 2018 and was last edited February 24th, 2022. They are looking for 75 individuals total at 2 different locations."
Answered by AI
Have there been other trials like this one before?
"Glycine Buffer is being trialed in 3 separate ongoing studies, located in 2 distinct countries. The first trial for this medication was back in 2007 and 22 have been conducted since then. That initial study, sponsored by Baxter Healthcare Corporation, completed its Phase 4 drug approval stage after 4640 participants had been involved."
Answered by AI
Can elderly patients participate in this research?
"This trial is only enrolling patients aged 18 to 50. There are 239 other clinical trials for patients younger than this age bracket and 698 for patients above 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Indiana University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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