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Trial record 5 of 32 for:    Cough | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Albuterol to Improve Respiratory Strength in SCI

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ClinicalTrials.gov Identifier: NCT02508311
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : April 17, 2018
Sponsor:
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 Not Applicable

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.


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 : December 31, 2018
Estimated Study Completion Date : June 28, 2019


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.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02508311


Contacts
Contact: Tradd Cummings, MS BS (718) 584-9000 ext 3107 tradd.cummings@va.gov
Contact: Greg Schilero, MD (715) 584-9000 ext 6701 Gregory.Schilero@va.gov

Locations
United States, New York
James J. Peters VA Medical Center, Bronx, NY Recruiting
Bronx, New York, United States, 10468
Contact: Miroslav Radulovic, MD    718-584-9000 ext 5472    miroslav.radulovic@va.gov   
Contact: Tradd Cummings, MS BS    (718) 584-9000 ext 3107    tradd.cummings@va.gov   
Principal Investigator: Greg Schilero, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Greg Schilero, MD James J. Peters Veterans Affairs Medical Center

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02508311     History of Changes
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: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
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:
Tetraplegia
High Paraplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Muscle Weakness
Paresis
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
Signs and Symptoms
Albuterol
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