Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00755079
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 92
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Drug: extended release beta-2 adrenergic agonist; Drug: placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 group of persons with spinal cord injury will receive blinded placebo capsule	Drug: placebo; An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
Experimental: Arm 2 group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule	Drug: extended release beta-2 adrenergic agonist; Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.

Outcome Measures

Primary Outcome Measures

1. Inspiratory Respiratory Muscle Strength [Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.]

   Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.

Secondary Outcome Measures

1. Expiratory Respiratory Muscle Strength [Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.]

   Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic Spinal Cord Injury (>1 year post-injury)

• All American Spinal Injury Association (ASIA) classifications

• High Paraplegia (level of injury T1-T6)

• Tetraplegia (level of injury C2-C8, non-ventilator dependent)

Exclusion Criteria:

• history of asthma

• uncontrolled hypertension or cardiovascular disease

• those using beta-2 adrenergic agonists

• epilepsy or seizure disorder

• hyperthyroidism

• chronic corticosteroid use

• those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression

• hypersensitivity to albuterol or any of its' delete components

• pregnancy

• use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:

• creatine monohydrate

• anabolic steroids (e.g., testosterone)

• growth hormone and their analogs and/or derivatives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Bronx	Bronx	New York	United States	10468

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Greg Schilero, MD, VA Medical Center, Bronx

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00755079
• Other Study ID Numbers: B4162-C
• First Posted: Sep 18, 2008
• Last Update Posted: Mar 17, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by US Department of Veterans Affairs: spinal cord injury; beta-2 agonist; respiratory muscle strength; pulmonary function test
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Adrenergic Agents; Adrenergic Agonists

Study Results

Participant Flow

Arm/Group Title	Placebo Control	Active Drug
Arm/Group Description	group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.	group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
Period Title: Overall Study
STARTED	18	22
COMPLETED	17	16
NOT COMPLETED	1	6

Baseline Characteristics

Arm/Group Title	Placebo	Active Drug	Total
Arm/Group Description	group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.	group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.	Total of all reporting groups
Overall Participants	17	16	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.24 (9.53)	42.75 (14.74)	42.48 (12.14)
Sex: Female, Male (Count of Participants)
Female	1 5.9%	1 6.3%	2 6.1%
Male	16 94.1%	15 93.8%	31 93.9%
Region of Enrollment (participants) [Number]
United States	17 100%	16 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Inspiratory Respiratory Muscle Strength
Description	Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Time Frame	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Control	Active Drug
Arm/Group Description	group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.	group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
Measure Participants	17	16
Maximal Inspiratory Pressure Baseline	82.35 (18.07)	79.19 (29.72)
Maximal Inspiratory Pressure 12wk Post	85.31 (24.51)	91.69 (32.04)

2. Secondary Outcome

Title	Expiratory Respiratory Muscle Strength
Description	Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Time Frame	Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Control	Active Drug
Arm/Group Description	group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.	group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
Measure Participants	17	16
Maximal Expiratory Pressure Baseline	84.65 (36.82)	70.38 (35.95)
Maximal Expiratory Pressure 12 week	88.31 (30.12)	77.44 (37.89)

Adverse Events

Arm/Group Title	Placebo		Active Drug
Arm/Group Description	group of persons with spinal cord injury will receive blinded placebo capsule placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.		group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
All Cause Mortality
	Placebo		Active Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Active Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		1/22 (4.5%)
Musculoskeletal and connective tissue disorders
Muscle Cramping	0/18 (0%)	0	1/22 (4.5%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Active Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.