Albuterol to Improve Respiratory Strength in SCI

NCT02508311 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: B1910-PSCH-15-011
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Respiratory Muscle Weakness

Keywords

Tetraplegia; High Paraplegia

Outcome Measures

Primary Outcomes (1)

• Change in Respiratory Muscle Strength

  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.

  Baseline, Week 16, Week 18

Study Arms (2)

Active Oral Beta-2

ACTIVE COMPARATOR

Subjects will receive 16 weeks of active medication.

Drug: Oral Albuterol Extended Release

Placebo

PLACEBO COMPARATOR

Subjects will receive 16 weeks of placebo medication.

Drug: Placebo

Interventions

Oral Albuterol Extended Release DRUG

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.

Also known as: VoSpire

Active Oral Beta-2

Placebo DRUG

Subjects will receive placebo tablets twice daily for 16 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 cm H2O or
• Females with maximal inspiratory pressure (MIP) \< 65 cm H2O

You may not qualify if:

• 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:

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

Inability to perform study during COVID-19. Albuterol repetabs are also no longer being manufactured.

Results Point of Contact

• Title: Gregory Schilero
• Organization: James J Peters VA Medical Center

gregory.schilero@va.gov

7185849000

Study Officials

• Greg Schilero, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 24, 2015
• Study Start: June 1, 2016
• Primary Completion: March 2, 2022
• Study Completion: February 28, 2023
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)