What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) include beta-2 adrenergic agonists like Albuterol, which are being studied for their potential to improve respiratory muscle strength. Known side effects of beta-2 adrenergic agonists include tremors, nervousness, headache, tachycardia (rapid heart rate), and palpitations. These medications can also cause muscle cramps and, in some cases, hypokalemia (low potassium levels). It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically targeting respiratory muscle strength in Spinal Cord Injury (SCI) patients using Beta-2 Adrenergic Agonists like Albuterol. Current research is exploring the effectiveness of sustained-release oral Albuterol for improving respiratory muscle strength and cough effectiveness in SCI patients. However, no specific FDA approvals for this indication are mentioned in the provided context.

What other types of research exist?

Promising novel alternatives to Albuterol for Spinal Cord Injury patients may include long-acting beta-agonists (LABAs) combined with muscarinic antagonists or inhaled corticosteroids, as well as disease-modifying treatments like sodium phenylbutyrate/taurursodiol, which have shown potential in improving respiratory function in other conditions.

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Beta-2 Agonist

Albuterol for Respiratory Muscle Weakness in Spinal Cord Injury

Q: What is the mechanism of action of this treatment?

Beta-2 adrenergic agonists, such as Albuterol, work by stimulating beta-2 receptors in the respiratory muscles, leading to muscle relaxation and bronchodilation. This mechanism helps improve airflow and respiratory muscle strength, which is crucial for SCI patients who often suffer from respiratory complications due to muscle weakness. By enhancing cough effectiveness and reducing mucus retention, these treatments can significantly decrease the risk of lung collapse and pneumonia, thereby improving overall respiratory function and reducing morbidity and mortality in SCI patients.

Phase 4

Waitlist Available

Led By Greg Schilero, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neurological level of injury between T1-T6 (High Paraplegia)

Males with maximal inspiratory pressure (MIP) < 90 cmH2O or Females with maximal inspiratory pressure (MIP) < 65 cmH2O

Must not have

Hyperthyroidism

Active respiratory disease or recent (within 3 months) respiratory infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 16, week 18

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if taking a specific medication can help people with severe spinal injuries strengthen their breathing muscles and improve their ability to cough. The goal is to reduce serious lung problems like pneumonia.

Who is the study for?

This trial is for adults aged 18-80 with spinal cord injury (SCI) at certain levels, causing respiratory muscle weakness. It's open to those who've had SCI for over a year and have specific inspiratory pressure measurements. Smokers, ventilator-dependent individuals, those with recent respiratory issues or certain medical conditions like hyperthyroidism, uncontrolled hypertension, or epilepsy are excluded.

What is being tested?

The study tests if oral Albuterol Extended Release can strengthen the respiratory muscles and improve cough in people with SCI over 16 weeks. Participants will either receive this medication or a placebo without active ingredients to compare effects.

What are the potential side effects?

Albuterol may cause side effects such as shaking hands, headaches, fast heart rate, dizziness, sore throat and muscle pain. Some might experience more serious reactions like chest pain or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is between my upper and middle back.

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My breathing strength is below the normal range.

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My spinal cord injury is between my neck and upper back.

Exclusion Criteria

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

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I have an overactive thyroid.

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I have a lung condition or had a lung infection in the last 3 months.

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I do not have uncontrolled high blood pressure or heart disease.

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I have a history of epilepsy or seizures.

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I use or might be using supplements or medications that boost muscle growth.

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I am currently on corticosteroids.

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I am currently on monoamine oxidase inhibitors or tricyclic antidepressants.

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I am currently using a beta-2 adrenergic agonist medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 16, week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 16, week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16, week 18 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Respiratory Muscle Strength

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Oral Beta-2Active Control1 Intervention

Subjects will receive 16 weeks of active medication.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive 16 weeks of placebo medication.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Beta-2 adrenergic agonists, such as Albuterol, work by stimulating beta-2 receptors in the respiratory muscles, leading to muscle relaxation and bronchodilation. This mechanism helps improve airflow and respiratory muscle strength, which is crucial for SCI patients who often suffer from respiratory complications due to muscle weakness. By enhancing cough effectiveness and reducing mucus retention, these treatments can significantly decrease the risk of lung collapse and pneumonia, thereby improving overall respiratory function and reducing morbidity and mortality in SCI patients.

Systemic administration of a β2-adrenergic receptor agonist reduces mechanical allodynia and suppresses the immune response to surgery in a rat model of persistent post-incisional hypersensitivity.Stimulation of spinal dorsal horn β2-adrenergic receptor ameliorates neuropathic mechanical hypersensitivity through a reduction of phosphorylation of microglial p38 MAP kinase and astrocytic c-jun N-terminal kinase.