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Albuterol to Improve Respiratory Strength in SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02508311
Recruitment Status : Active, not recruiting
First Posted : July 24, 2015
Last Update Posted : January 14, 2021
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Spinal cord injury (SCI), especially involving the cervical and upper thoracic segments, can significantly compromise respiratory muscle function. Respiratory complications can ensue, including lung collapse and pneumonia, which are the primary cause for mortality in association with traumatic SCI both during the acute and chronic phases post-injury. Lesions at the level of the cervical or high thoracic spinal cord result in respiratory muscle weakness, which is associated with ineffective cough, mucus retention, and mucus plugging. Despite the fact that pulmonary complications are a major cause of morbidity and mortality in this population, there is a paucity of effective interventions in the SCI population known to improve respiratory muscle strength with pharmacologic interventions receiving little to no attention. The current objective of this study is to determine the effectiveness of 16 weeks of sustained release oral Albuterol to; (1) improve respiratory muscular strength, and (2) improve cough effectiveness.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Respiratory Muscle Weakness Drug: Oral Albuterol Extended Release Drug: Placebo Phase 4

Detailed Description:

Although the past 40 years has witnessed a substantial improvement in the acute and chronic management of persons with SCI, mortality remains high during the first year post-injury, and pulmonary complications including pneumonia, lung collapse (atelectasis), respiratory failure, and thromboembolism are the predominant cause. The propensity for pulmonary complications among subjects with SCI stems from paralysis of respiratory muscles. Injury to the cervical and upper thoracic cord significantly compromises function of the diaphragm, intercostal muscles, accessory respiratory muscles, and abdominal muscles. Respiratory muscle dysfunction is manifest as diminution in lung volumes, reduction in maximal static inspiratory and expiratory mouth pressures (MIP and MEP, respectively), and reduction in peak cough pressure and flow. Cough effectiveness is contingent upon both inspiratory and expiratory muscle strength; increasing the pressure-generating capacity of the inspiratory and expiratory muscles in persons with tetraplegia and high paraplegia may, therefore, translate to improved cough effectiveness and reduction in the propensity for atelectasis and, possibly, pneumonia.

Respiratory muscle training, often utilizing simple hand-held portable resistive or threshold training devices, appears to have marginal effects on vital capacity and maximal static mouth inspiratory and expiratory pressures (MIP and MEP, respectively), although data is inconclusive. Pharmacologic interventions to improve respiratory muscle strength have received little attention in the SCI population. Studies involving oral beta-2 adrenergic agonists, which have been shown to elicit anabolic effects on skeletal muscle in young men and an increase in muscle strength among patients with facioscapulohumeral muscular dystrophy, have also demonstrated salutary effects in persons with SCI. There are many foreseeable advantages of a pharmacologic approach to improve respiratory muscle strength in persons with SCI. For instance, RMT can be physically demanding and time consuming, compliance can be an issue, and sustainable improvements have not been realized. The intent in the present proposal is to enroll a targeted cohort of 24 comparatively weaker subjects with tetraplegia and high paraplegia in a randomized, double-blind, placebo-controlled, parallel group trial to assess the effects of an oral beta-2 agonist upon respiratory muscle strength and cough effectiveness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in SCI
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : June 2, 2024

Arm Intervention/treatment
Active Comparator: Active Oral Beta-2
Subjects will receive 16 weeks of active medication.
Drug: Oral Albuterol Extended Release
Subjects will receive extended release Albuterol, 4mg twice daily for the first week. The remaining 15 weeks subjects will receive extended release Albuterol, 8mg twice daily.
Other Name: VoSpire

Placebo Comparator: Placebo
Subjects will receive 16 weeks of placebo medication.
Drug: Placebo
Subjects will receive placebo tablets twice daily for 16 weeks.

Primary Outcome Measures :
  1. Change in Respiratory Muscle Strength [ Time Frame: Baseline, Week 16, Week 18 ]
    Respiratory muscle strength will be determined by maximal inspiratory pressure and maximal expiratory pressure at the mouth during baseline visit, week 16 visit and week 18 visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or Female age 18 to 80
  • Chronic spinal cord injury ( 1 year since injury)
  • Neurological level of injury between C3-C8 (Tetraplegia)
  • 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

Exclusion Criteria:

  • Smoking, active or history of smoking with the past year
  • Ventilator Dependence
  • History of blast injuries to the chest
  • Antidepressant use
  • History of asthma
  • Active respiratory disease or recent(within 3 months) respiratory infections
  • Uncontrolled hypertension or cardiovascular disease
  • Current use a beta-2 adrenergic agonists
  • History of epilepsy or seizure disorder
  • Hyperthyroidism
  • Currently taking corticosteroids
  • Currently taking monoamine oxidase inhibitors or tricyclic antidepressants
  • Hypersensitivity to albuterol or any of its' constituents
  • Pregnant
  • Use or are suspected of using over-the counter supplements or prescribed medications with anabolic characteristics (promotes improvements to muscle mass and strength) including, but not limited to:

    • creatine monohydrate
    • anabolic steroids (e.g., testosterone)
    • growth hormone
    • substances with similar actions or indications as those listed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02508311

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United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Greg Schilero, MD James J. Peters Veterans Affairs Medical Center
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Responsible Party: VA Office of Research and Development Identifier: NCT02508311    
Other Study ID Numbers: B1910-P
SCH-15-011 ( Other Identifier: James J. Peters Veterans Affairs Medical Center )
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD data is not available at this time.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
High Paraplegia
Additional relevant MeSH terms:
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Muscle Weakness
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action