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NCT02508311 · ClinicalTrials.gov registry record · Phase 4
Albuterol to Improve Respiratory Strength in SCI
A Phase 4 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02508311: Clinical Trial Phase 4 study, sponsored by VA Office of Research and Development.
NCT02508311 is a Phase 4 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508311, a Phase 4 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Oral Albuterol Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 4 |
Why NCT02508311 stopped before completion
NCT02508311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02508311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02508311 about?
NCT02508311 is a clinical study titled "Albuterol to Improve Respiratory Strength in SCI". 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 b...
What is the current status of trial NCT02508311?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2016-06-01. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT02508311?
The interventions under investigation include: Placebo (DRUG), Oral Albuterol Extended Release (DRUG).
Who is sponsoring clinical trial NCT02508311?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02508311's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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