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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02508311|
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Respiratory Muscle Weakness||Drug: Oral Albuterol Extended Release Drug: Placebo||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 1, 2019|
|Estimated Study Completion Date :||June 28, 2019|
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.
Subjects will receive placebo tablets twice daily for 16 weeks.
- 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.
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
|Contact: Greg Schilero, MD||(715) 584-9000 ext 6701||Gregory.Schilero@va.gov|
|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 email@example.com|
|Contact: Miroslav Radulovic, MD (718) 584-9000 ext 5472 firstname.lastname@example.org|
|Principal Investigator: Greg Schilero, MD|
|Principal Investigator:||Greg Schilero, MD||James J. Peters Veterans Affairs Medical Center|