Propranolol for Hypoxia

Overseen By Jacqueline K Limberg, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Missouri-Columbia

Must not be taking: Hormonal contraceptives, Prescription medications

Disqualifiers: Sleep apnea, Cardiovascular, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how men and women differ in their body's response to low oxygen levels, specifically examining the impact on blood vessel function. Participants will take propranolol, a medication often used to treat high blood pressure, to determine if it alters this response. The trial requires wearing a mask to control oxygen levels in the body. This study suits healthy adults who do not smoke or use nicotine and have no major health issues like sleep apnea or high blood pressure. As an Early Phase 1 trial, the research focuses on how propranolol affects the body's response to low oxygen levels.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current prescription medications to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that propranolol is generally safe for people. Studies have found it can help reduce sudden heart-related deaths in those at high risk, indicating it works well and is usually well-tolerated. For individuals with heart conditions, propranolol appears safe, with the most common side effects being mild. These may include a slower heart rate, low blood pressure, and low blood sugar, though they are not very common. The FDA has approved propranolol for treating heart issues, supporting its safety. Overall, evidence suggests it is generally safe, although some side effects can occur. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for hypoxia?

Unlike standard treatments for hypoxia, which often include oxygen therapy and medications to stimulate breathing, propranolol hydrochloride is being explored for its unique potential to manage the body's response to low oxygen levels. Propranolol is a beta-blocker typically used for heart conditions, but researchers are excited because it might help regulate the cardiovascular effects of hypoxia differently, potentially offering a new way to maintain stable oxygen levels in the body. This novel approach could provide alternative benefits by targeting the physiological responses to hypoxia rather than just addressing oxygen deficiency directly.

What evidence suggests that Propranolol Hydrochloride might be an effective treatment for hypoxia?

Research has shown that propranolol effectively treats high blood pressure and chest pain related to heart problems. In studies comparing propranolol tablets and liquid forms, patients taking tablets experienced significant improvements. Propranolol can also temporarily affect important functions in premature babies, but these effects are not serious. The treatment generally helps manage heart rate and blood pressure. While propranolol is commonly used for certain heart conditions, its effectiveness for low oxygen levels in the body remains under investigation in this trial. ^{1 2 6 7 8}

Who Is on the Research Team?

Jacqueline K Limberg, Ph.D.

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for healthy adults, both men and women aged between 18-45 with a BMI of 18-30. Participants must not be pregnant, breastfeeding, or using nicotine products. Those with high blood pressure, nerve diseases, diabetes, PCOS, drug use issues, recent COVID-19 symptoms, sleep apnea or major organ diseases are excluded.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 30.

Non-pregnant and non-breastfeeding

You do not use nicotine.

Exclusion Criteria

I have recently been diagnosed with COVID-19 and am showing symptoms.

Your blood pressure is higher than 140/90 mmHg.

I have a nerve or neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hypoxia Exposure

Men and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.

1 session

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Normal Saline
• Placebo
• Propranolol Hydrochloride

Trial Overview The study aims to understand how low oxygen levels affect blood vessel responses differently in men and women by comparing the effects of a Propranolol pill (a beta-blocker) versus a placebo (inactive pill).

How Is the Trial Designed?

Group I: Hypoxia Exposure Experimental Treatment 2 Interventions

Men and women will be exposed to isocapnic hypoxia. Participants will wear a mask and systemic oxygen levels will be titrated to attain hypoxemia as assessed by pulse oximetry.

Propranolol Hydrochloride is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

Approved in European Union as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

Approved in Canada as Inderal for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Performance anxiety

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Propranolol is a versatile noncardioselective β-blocker used to treat various conditions, including hypertension, anxiety disorders, and migraine prophylaxis, highlighting its efficacy in managing both cardiovascular and non-cardiovascular symptoms.

The study provides a comprehensive profile of propranolol, detailing its physicochemical properties and pharmacological actions, which are essential for understanding its therapeutic uses and potential interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propranolol. Al-Majed, AA., Bakheit, AHH., Abdel Aziz, HA., et al.[2017]

Controlled-release formulations of propranolol, specifically Elanol and Inderal LA, provide smoother serum level profiles and delayed peak times compared to conventional propranolol, indicating a potentially more stable therapeutic effect.

Elanol showed greater bioavailability than Inderal LA, suggesting that long-acting formulations can be effective without the drawbacks of reduced bioavailability due to first-pass metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic studies with a new controlled-release formulation of propranolol in normal volunteers: a comparison with other commercially available formulations. Perucca, E., Grimaldi, R., Gatti, G., et al.[2019]

In a single-blind study involving 13 patients with mild to moderately severe hypertension, the combination of propranolol (80 mg) and bendrofluazide (2.5 mg) effectively controlled blood pressure in 12 patients over a 12-week period.

The treatment did not result in significant changes in biochemical parameters or ECG readings, and no serious side effects were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fixed ratio combination of propranolol and bendrofluazide in the treatment of hypertension. Pandhi, P., Sharma, BK., Sharma, PL., et al.[2013]

Long-acting propranolol (Inderal LA) provides a controlled release of the medication, maintaining higher plasma concentrations over 24 hours compared to conventional tablets, which helps ensure consistent beta-adrenoceptor blockade.

This formulation is equally effective for treating conditions like angina pectoris, hypertension, and hyperthyroidism, while potentially improving patient adherence to treatment due to simplified dosing regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting propranolol (Inderal LA): pharmacokinetics, pharmacodynamics and therapeutic use. Mishriki, AA., Weidler, DJ.[2019]

A study involving six healthy adult volunteers tested four different brands of propranolol (Inderal, Ciplar, Corbeta, and Propal) to assess variations in how the body absorbs and responds to the medication.

The results showed no significant differences in the pharmacokinetic (how the drug is processed in the body) and pharmacodynamic (the drug's effects on the body) parameters among the brands, indicating they are likely interchangeable in terms of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. Biswas, NR., Garg, SK., Kumar, N., et al.[2013]

The study analyzed data from the Canadian Adverse Drug Reaction Monitoring Program to assess the potential link between propranolol hydrochloride and bradycardia, finding that the signals for bradycardia were not statistically significant despite some high calculated statistics.

Although the results did not confirm a strong association between propranolol and bradycardia, the authors suggest that further investigation using larger databases is warranted due to the observed trends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride. Gavali, DK., Kulkarni, KS., Kumar, A., et al.[2021]

Citations

1. withpower.com withpower.com/trial/propranolol-for-hypoxia-20372

Propranolol for Hypoxia · Info for Participants Propranolol is known to be effective in treating conditions like hypertension (high blood pressure) and angina pectoris (chest pain due to heart issues), as it ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11832506/

Efficacy and safety assessment of propranolol tablets vs. ... 23.21% of patients in the propranolol tablet group and 42.42% in the oral solution group achieved >75% score improvement (X2 = 8.557; P = 0.003) ...

3. journals.lww.com journals.lww.com/jocn/fulltext/2020/09020/long__and_short_term_effects_of_propranolol.3.aspx

Long- and Short-Term Effects of Propranolol Hydrochloride... When used on very preterm infants, PH may have some temporary effects on the patients' vital functions in the short term; however, no serious side effects were ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/018553Orig1s048s052lbl.pdf

Inderal® LA (propranolol hydrochloride) Long-Acting Capsules Inderal LA was as effective as conventional propranolol for exercise heart rate, systolic and diastolic blood pressure, duration of anginal pain ...

5. nature.com nature.com/articles/pr2016230

Propranolol 0.1% eye micro-drops in newborns with ... Propranolol 0.1% eye micro-drops are well tolerated, but not sufficiently effective. Further studies are required to identify the optimal dose and ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/016418s080,016762s017,017683s008lbl.pdf

Inderal (propranolol hydrochloride) Tablets Rx only This ... Compared with placebo, total mortality was reduced 39% at 12 months and. 26% over an average follow-up period of 25 months. The Norwegian Multicenter Trial in ...

7. nature.com nature.com/articles/s41598-024-84653-0

Efficacy and safety of propranolol tablets vs. oral solution in ... Regarding the primary outcome, the effective response rate was 87.9% (51 individuals) in the propranolol hydrochloride oral solution group and ...

8. dovepress.com dovepress.com/propranolol-in-the-treatment-of-infantile-hemangiomas-peer-reviewed-fulltext-article-CCID

Propranolol in the Treatment of Infantile Hemangiomas Propranolol has been considered safe with fewer adverse effects ... The other serious outcomes like bradycardia, hypotension, and hypoglycemia are ...