Spinal Cord InjuryPhase 2/3NCT00755079
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury
A Phase 2/3 study testing extended release beta-2 adrenergic agonist in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- extended release beta-2 adrenergic agonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2014
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- history of asthma
- uncontrolled hypertension or cardiovascular disease
- those using beta-2 adrenergic agonists
- epilepsy or seizure disorder
- hyperthyroidism
- chronic corticosteroid use
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spinal Cord Injury
- Being tested
- extended release beta-2 adrenergic agonist, placebo
- Keywords
- spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended release beta-2 adrenergic agonistDrug
Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles.
placeboDrug
An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | group of persons with spinal cord injury will receive blinded placebo capsule Receives: Drug: placebo |
| Arm 2 | Experimental | group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule Receives: Drug: extended release beta-2 adrenergic agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Respiratory Muscle Strength
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Measured: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Secondary outcomes (1)
Expiratory Respiratory Muscle Strength
Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.
Measured: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2012
- Study completionDec 2014
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Greg Schilero, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755079
- Sponsor's protocol ID
- B4162-C
- Status last verified
- Feb 2015
- First submitted
- 15 Sep 2008
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00755079
- Acronym / sponsor ID
- B4162-C
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, beta-2 agonist, respiratory muscle strength, pulmonary function test
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: placebogroup of persons with spinal cord injury will receive blinded placebo capsule |
| Arm 2 | Experimental | Drug: extended release beta-2 adrenergic agonistgroup of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- history of asthma
- uncontrolled hypertension or cardiovascular disease
- those using beta-2 adrenergic agonists
- epilepsy or seizure disorder
- hyperthyroidism
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 |
|---|---|---|
| extended release beta-2 adrenergic agonistAlbuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles. | Drug | Arm 2 |
| placeboAn ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function. | Drug | Arm 1 |
Primary outcome
Inspiratory Respiratory Muscle Strength
Time frame: 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.
1 secondary outcome
Expiratory Respiratory Muscle Strength
Time frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing extended release beta-2 adrenergic agonist in people with Spinal Cord Injury, run by US Department of Veterans Affairs 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 17 Mar 2015. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jul 2014). 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?
Inspiratory Respiratory Muscle Strength (time frame: Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.). 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 17 Mar 2015.