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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Airway pH imbalances cause numerous adverse physiological changes within the airways, including hyperreactivity, cough, bronchoconstriction, ciliopathy, decreased response to bronchodilators, bacterial growth, nitrosative/oxidative stress, neutrophilic/eosinophilic inflammation, and cell death. Airway pH is known to be low (acidic) in chronic and acute pulmonary diseases. The gold standard approach to measuring airway pH is to bronchscopically obtain epithelial cell lining fluid using protected brush sampling. The expense and invasive nature of this approach is a barrier to fully characterizing the role of airway pH in the health and disease. In this study, we will evaluate non-invasive clinical methods that can be done using equipment standard in clinical pulmonary function laboratories for measuring airway pH.

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.

How does the drug Alkaline glycine differ from other asthma treatments?

Alkaline glycine is unique because it involves an alkaline buffer, which may help neutralize acidity in the airways, potentially reducing inflammation and irritation differently than standard asthma treatments that often focus on bronchodilation or anti-inflammatory effects. This approach could offer a novel mechanism of action compared to traditional therapies. ^{1 2 3 4 5}

Eligibility Criteria

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.

I am between 18 and 60 years old with a respiratory disorder or no lung disease.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Inhaled lysine-aspirin as a bronchoprovocation procedure in aspirin-sensitive asthma: its repeatability, absence of a late-phase reaction, and the role of histamine. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A screening test for airways reactivity. An abbreviated methacholine inhalation challenge. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Inhaled allergen bronchoprovocation tests. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Allergen provocation tests in respiratory research: building on 50 years of experience. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

EAACI position paper on the clinical use of the bronchial allergen challenge: Unmet needs and research priorities. [2022]