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Beta-2 Agonist

Albuterol for Respiratory Muscle Weakness in Spinal Cord Injury

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16, week 18
Awards & highlights

Study Summary

This trial is testing whether 16 weeks of Albuterol can help improve respiratory strength and cough effectiveness for people with Spinal Cord Injury.

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.Check my eligibility
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.See study design
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.
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I have had a spinal cord injury for over a year.
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I am between 18 and 80 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Respiratory Muscle Strength

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,608 Previous Clinical Trials
3,306,238 Total Patients Enrolled
Greg Schilero, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Albuterol Extended Release (Beta-2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02508311 — Phase 4
Spinal Cord Injury Research Study Groups: Active Oral Beta-2, Placebo
Spinal Cord Injury Clinical Trial 2023: Albuterol Extended Release Highlights & Side Effects. Trial Name: NCT02508311 — Phase 4
Albuterol Extended Release (Beta-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02508311 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized Active Oral Beta-2 for utilization?

"Data from prior clinical trials suggests that Active Oral Beta-2 is safe enough to have earned a rating of 3 on our scale. This treatment has already been approved for public use, signifying Phase 4 status."

Answered by AI

What is the capacity of enrolled participants in this research endeavor?

"Currently, this trial is not recruiting at present. Initially posted on June 1st 2016 and last edited November 8th 2022, interested patients should look towards the 423 studies actively seeking participants with asthenia or 17 trials for Active Oral Beta-2 which are currently accepting volunteers."

Answered by AI

Are there any opportunities available to participate in this experiment?

"Contrary to expectations, clinicaltrials.gov does not showcase that this study is seeking for participants; the trial was posted on June 1st 2016 and last updated November 8th 2022. Nevertheless, there are 440 other active trials currently recruiting patients."

Answered by AI

Is there a specific demographic suitable for enrollment in this research endeavor?

"This medical trial is recruiting up to 5 individuals aged 18-80 years old with asthenia, who also meet the following conditions: male or female tetraparetic patients (C3 - C8) or high paraplegic patients (T1 - T6), and males with a maximal inspiratory pressure of less than 90 cmH2O, or females with an MIP below 65 cmH2O."

Answered by AI

Is the age requirement for this research limited to individuals under 25?

"The age range for this medical experiment is between 18 and 80 years old as stated in the trials eligibility criteria."

Answered by AI

What type of medical conditions is Active Oral Beta-2 typically employed for?

"The common application for Active Oral Beta-2 is to alleviate exercise-induced bronchospasm, however it can also be prescribed as a treatment option for various other ailments such as respiratory tract infections and bronchodilator agents."

Answered by AI

Has Active Oral Beta-2 been the subject of other research investigations?

"Currently, 17 scientific trials are underway to study the effects of Active Oral Beta-2. None of these studies have advanced to phase 3 yet; however they are being conducted at 75 sites across San Francisco, California."

Answered by AI
~1 spots leftby Apr 2025