Spinal Cord InjuryPhase 4NCT02508311
Albuterol to Improve Respiratory Strength in SCI
A Phase 4 study testing Oral Albuterol Extended Release in people with Spinal Cord Injury and Respiratory Muscle Weakness, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injury, Respiratory Muscle Weakness
- What is being tested?
- Oral Albuterol Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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:
- creatine monohydrate
- anabolic steroids (e.g., testosterone)
- growth hormone
- substances with similar actions or indications as those listed
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: The Effect of an Oral Beta-2 Agonist on Respiratory Muscle 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 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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury, Respiratory Muscle Weakness
- Being tested
- Oral Albuterol Extended Release, Placebo
- Keywords
- Tetraplegia, High Paraplegia
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Albuterol Extended ReleaseDrug
Also called VoSpire
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.
PlaceboDrug
Subjects will receive placebo tablets twice daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Oral Beta-2 | Active comparator | Subjects will receive 16 weeks of active medication. Receives: Drug: Oral Albuterol Extended Release |
| Placebo | Placebo comparator | Subjects will receive 16 weeks of placebo medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16, Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study start1 Jun 2016
- Primary completion2 Mar 2022
- Study completion28 Feb 2023
Why it stopped: Our ability to test subjects with tetraplegia in this interventional study was interrupted by the COVID-19 pandemic. Our research pharmacist also informed us that oral albuterol is no longer being manufactured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Greg Schilero, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508311
- Sponsor's protocol ID
- B1910-P
- Other IDs
- SCH-15-011
- Status last verified
- Apr 2024
- First submitted
- 15 Jul 2015
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data is not available at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in SCI
- ClinicalTrials.gov ID
- NCT02508311
- Acronym / sponsor ID
- B1910-P
- Conditions
- Spinal Cord Injury, Respiratory Muscle Weakness
- Keywords
- Tetraplegia, High Paraplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our ability to test subjects with tetraplegia in this interventional study was interrupted by the COVID-19 pandemic. Our research pharmacist also informed us that oral albuterol is no longer being manufactured.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Oral Beta-2 | Active comparator | Drug: Oral Albuterol Extended ReleaseSubjects will receive 16 weeks of active medication. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive 16 weeks of placebo medication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- Smoking, active or history of smoking with the past year
- Ventilator Dependence
- History of blast injuries to the chest
- Antidepressant use
- History of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Albuterol Extended ReleaseAlso: VoSpireSubjects 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. | Drug | Active Oral Beta-2 |
| PlaceboSubjects will receive placebo tablets twice daily for 16 weeks. | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD data is not available at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Schilero, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Albuterol Extended Release in people with Spinal Cord Injury and Respiratory Muscle Weakness, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Muscle Strength (time frame: Baseline, Week 16, Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.