Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02508311 |
| Other study ID # |
B1910-P |
| Secondary ID |
SCH-15-011 |
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2016 |
| Est. completion date |
February 28, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
