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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

Must not have

Individuals with renal failure or creatinine > 1.8 mg/dl at time of screening

Current use of a vitamin K antagonist (warfarin) or other anticoagulant (e.g., heparin, clopidogrel, enoxaparin or dalteparin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My creatinine level is not above 1.8 mg/dl.

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I am currently taking blood thinners like warfarin or heparin.

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I am currently being treated for a non-tuberculous mycobacterial infection.

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My liver enzymes are high, or I have a history of liver issues.

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I've had more than 3 flare-ups of my condition in the last 6 months.

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My condition does not meet the specific exclusions for cystic fibrosis.

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I have not had significant coughing up of blood in the past year.

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I have a condition or throat issue that makes bronchoscopy risky.

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I am allergic to anesthesia used in bronchoscopy.

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I am currently taking beta-blockers, antidepressants, meperidine, or nitrates.

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I have a blood disorder that affects clotting or oxygen delivery.

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I was put on a breathing machine for asthma in the last year.

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I have a history of high blood pressure in the lungs.

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I cannot do consistent breathing tests.

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I need extra oxygen or my oxygen levels are often below 92%.

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I am severely malnourished.

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I do not have severe asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 31Eligibility criteria met