Alkaline Buffer Challenge for Asthma

Overseen By Rachel Owensby

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Disqualifiers: Mechanical ventilation, Continuous oxygen therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Single visit, less than two hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure acidity in the airways of individuals with respiratory issues, such as asthma. Researchers aim to determine if inhaling alkaline glycine, a compound that may neutralize acidity, can balance airway pH and improve lung health. They seek participants aged 18 to 60 who either have a diagnosed respiratory disorder or are healthy non-smokers with no history of lung disease. Participants with stable lung conditions and no recent health changes may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in respiratory health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for guidance.

Is there any evidence suggesting that alkaline glycine is likely to be safe for humans?

Research has shown that inhaling alkaline glycine is safe for people. Studies have found no negative effects on lung function or vital signs such as heart rate or blood pressure. Participants in these studies, whether healthy or with lung conditions, responded well to the treatment. This suggests that inhaling alkaline glycine is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments, which typically include inhaled corticosteroids and bronchodilators, alkaline glycine offers a novel approach by focusing on balancing pH levels in the airways. Researchers are excited about this treatment because it uses a new delivery method—direct inhalation of alkaline glycine—that could potentially reduce airway inflammation without the side effects associated with steroids. This unique mechanism of action sets it apart, offering hope for a more natural and targeted way to manage asthma symptoms.

What evidence suggests that alkaline glycine might be an effective treatment for asthma?

Research has shown that inhaling alkaline glycine, the treatment under study in this trial, can safely reduce airway acidity without affecting lung function or vital signs. In one study, participants experienced lower levels of airway inflammation after using alkaline glycine. This treatment increases the pH level in the airways, potentially reducing issues like coughing and inflammation associated with asthma. Although further research is necessary, these early findings suggest that alkaline glycine could help manage asthma symptoms by balancing airway pH. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60, both healthy and those with respiratory disorders like asthma. Healthy participants should be non-smokers without chronic lung diseases or severe allergies needing special treatment. Those with pulmonary disease must have stable health and an FEV1 over 55%. People on mechanical ventilation, unable to cooperate in specimen collection, or having had a recent pulmonary issue are excluded.

Inclusion Criteria

I am 18-60 years old, a non-smoker, with no chronic lung diseases or severe allergies.

Subjects with pulmonary disease may include: Person with well-documented disease with objective diagnostics such a lung function or genetic testing, Person with FEV1 > 55% predicted on the day of study procedures, Person who is clinically stable with no significant changes in health status within 4 weeks.

Exclusion Criteria

Subjects that are unable or unwilling to cooperate with specimen collection.

You are currently using a machine to help you breathe.

I had a lung flare-up in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Subjects inhale alkaline glycine and measurements of compartmental FeNO and EBC pH are taken

Single visit, less than two hours

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Alkaline glycine

Trial Overview The study tests the use of alkaline glycine to determine airway pH levels as a non-invasive alternative to bronchoscopy. It aims to understand how airway acidity affects lung function and diseases by using standard clinical equipment found in pulmonary labs.

How Is the Trial Designed?

Group I: Alkaline glycine Inhalation Experimental Treatment 1 Intervention

Subjects inhale alkaline glycine

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7610037/

Safety of an Alkalinizing Buffer Designed for Inhaled ... RESULTS: Alkaline glycine inhalation was tolerated by all subjects in both studies, with no adverse effects on spirometric parameters or vital signs. Airway ...

2. withpower.com withpower.com/trial/phase-2-cystic-fibrosis-10-2018-b562c

Glycine Buffer for Airway pH Measurement in Asthma Inhalation of an alkaline glycine buffer safely alkalinizes the airways without causing any adverse effects on lung function or vital signs, as shown in a study ...

3. researchgate.net researchgate.net/figure/Comparison-of-alkaline-glycine-to-normal-saline-inhalation-study-1-Median-percentage_fig2_233964707

Comparison of alkaline glycine to normal saline inhalation ... F ENO levels decreased by a median of Ϫ 21.62% ( P ϭ .004) after study 1 glycine inhalation, but there was no significant change in F ENO in study 2. The ...

4. cdek.liu.edu cdek.liu.edu/trial/NCT03617718/

Trial | NCT03617718 This study is testing a non invasive way to measure airway pH in individuals with Asthma and Cystic Fibrosis using a new inhaled drug.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456969/

Inhaled alkaline hypertonic divalent salts reduce refractory ... Inhaled alkaline hypertonic divalent salt aerosol reduces cough frequency in refractory chronic cough patients with baseline cough rates in range 4–34 per h.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23258576/

Safety of an Alkalinizing Buffer Designed for Inhaled ... - PubMed Alkaline glycine inhalation was tolerated by all subjects in both studies, with no adverse effects on spirometric parameters or vital signs.