Spinal Cord InjuryPhase 1NCT01355991
Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
A Phase 1 study testing Tiotropium and Salmeterol in people with Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on: Fraction of expired NO (FeNO) Selected Biomarkers of inflammation in exhaled breath condensates (EBC) Pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Tiotropium and Salmeterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Spinal Cord Injury (>1 year post-injury)
- All American Spinal Injury Association (ASIA) classifications
- Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
- Age 18-65 years
Who cannot join
- Smoking, active or history of smoking within last 6 months;
- Active respiratory disease;
- Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- Use of medications known to affect the respiratory system;
- Use of medications known to alter airway caliber;
- Coronary heart and/or artery disease;
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- Hypertension;
- Adrenal insufficiency;
- Pregnancy;
- Severe Milk Protein Allergy;
- Lack of mental capacity to give informed consent;
- Previous allergic reaction or hypersensitivity to salmeterol or tiotropium;
- Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as:
- selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James J. Peters VA Medical Center
The Bronx, New York, 10468
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Acute and Chronic Effects of an Anticholinergic Agent or a Long-Acting Beta 2 Agonist on Levels of Exhaled Nitric Oxide and Pulmonary Function in Persons With Tetraplegia
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on:
- Fraction of expired NO (FeNO)
- Selected Biomarkers of inflammation in exhaled breath condensates (EBC)
- Pulmonary function, as measured by pulmonary function tests and body plethysmography
- Conditions
- Spinal Cord Injury
- Being tested
- Tiotropium, Salmeterol
- Keywords
- Spinal Cord Injury, Tetraplegia, Pulmonary Function, Bronchodilator
- 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.
TiotropiumDrug
18mcg/ capsule inhaled once daily for two weeks.
SalmeterolDrug
50mcg inhalation twice daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Anticholinergic Agent | Active comparator | Not described Receives: Drug: Tiotropium |
| Long Acting Beta 2 Agonist | Active comparator | Not described Receives: Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.
Measured: Approximately 8 weeks
Secondary outcomes (2)
Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
The subject will be randomized to receive either anticholinergic agent or long acting Beta2 agonist. Measurements of EBC will take place at baseline, 1 hr post drug administration, and two weeks after intervention. Biomarkers of inflammation will be assessed by collected exhaled breath condensates, which will subsequently be sent for biochemical analysis. Markers include Isoprostane-8, TNF-Alpha, and Leukotriene B4.
Measured: Approx. 8 weeks
Pulmonary function, as measured by pulmonary function tests and body plethysmography
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment. Pulmonary assessments include: Spirometry and Plethysmography.
Measured: Approx. 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Institute for Rehabilitation
- Responsible party
- Principal investigator, Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Miroslav Radulovic, MD, Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355991
- Sponsor's protocol ID
- 01327
- Status last verified
- Oct 2015
- First submitted
- 12 May 2011
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of an Anticholinergic Agent or a Long-Acting Beta 2 Agonist on Levels of Exhaled Nitric Oxide and Pulmonary Function in Persons With Tetraplegia
- ClinicalTrials.gov ID
- NCT01355991
- Acronym / sponsor ID
- 01327
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Tetraplegia, Pulmonary Function, Bronchodilator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Institute for Rehabilitation
- Study start
- Aug 2011
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on:
- Fraction of expired NO (FeNO)
- Selected Biomarkers of inflammation in exhaled breath condensates (EBC)
- Pulmonary function, as measured by pulmonary function tests and body plethysmography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticholinergic Agent | Active comparator | Drug: Tiotropium |
| Long Acting Beta 2 Agonist | Active comparator | Drug: Salmeterol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Spinal Cord Injury (>1 year post-injury)
- All American Spinal Injury Association (ASIA) classifications
- Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
- Age 18-65 years
Key exclusion criteria (14 listed)
- Smoking, active or history of smoking within last 6 months;
- Active respiratory disease;
- Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- Use of medications known to affect the respiratory system;
- Use of medications known to alter airway caliber;
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 |
|---|---|---|
| Tiotropium18mcg/ capsule inhaled once daily for two weeks. | Drug | Anticholinergic Agent |
| Salmeterol50mcg inhalation twice daily for two weeks | Drug | Long Acting Beta 2 Agonist |
Primary outcome
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
Time frame: Approximately 8 weeks
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.
2 secondary outcomes
Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
Time frame: Approx. 8 weeks
Pulmonary function, as measured by pulmonary function tests and body plethysmography
Time frame: Approx. 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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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.
Miroslav Radulovic, MD principal investigator
James J. Peters VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium and Salmeterol in people with Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites 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 14 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: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO) (time frame: Approximately 8 weeks). 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 23 Oct 2015.