Spinal Cord InjuryPhase 1NCT01353599
Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
A Phase 1 study testing Mometasone furoate in people with Spinal Cord Injury, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due to complete or partial loss of respiratory muscle innervation which is dependent upon the level and completeness of injury [2]. 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?
- Mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Mar 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
- 18 to 65 years old; and
- Stable, tetraplegia C3-C8 levels (duration of injury >1 year).
Who cannot join
- Smoking, active or history of smoking during the last six months
- Active respiratory disease(s), such as COPD, inflammatory lung disease, obstructive lung diseases, or acute respiratory infections
- No known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- Ventilator dependence;
- Use of medications known to affect the respiratory system, such as nizoral;
- aldesleukin
Show all 19Show fewer
- oral corticosteroids (e.g., prednisone, dexamethasone)
- natalizumab
- drugs affecting liver enzymes that remove mometasone from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine)
- Use of medications known to alter airway caliber;
- Coronary heart and/or artery disease, as indicated in the patient medical record;
- Hypertension, baseline blood pressure ≥ 140/90mHg;
- Adrenal insufficiency, as indicated in the patient medical record;
- Pregnancy;
- Lack of mental capacity to give informed consent;
- History of glaucoma;
- History of cataracts; and
- Persisting pressure ulcer, or a recently healed wound (e.g., ≤3 months since wound closure).
- History of a milk protein allergy
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
Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due to complete or partial loss of respiratory muscle innervation which is dependent upon the level and completeness of injury [2]. In addition, they share many aspects of obstructive airway physiology commonly associated with asthma. In asthma, physiological responses such as decrease in baseline airway caliber, bronchodilatation following inhalation of a beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely related to airway inflammation. The cause of such inflammation is unclear, and may be multi-factorial and attributable to: recurrent respiratory infections due to inability to effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional sympathetic innervation to the airways. Therefore, the investigators propose to test for the possible involvement the above mechanisms by pharmacological intervention, and to study effects of such intervention on overall pulmonary function and indirect measures of pulmonary inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile, pulmonary function tests, and cellular profile of the induced sputum.
- Conditions
- Spinal Cord Injury
- Being tested
- Mometasone furoate
- Keywords
- Spinal Cord Injury, Tetraplegia, Pulmonary Function
- 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.
Mometasone furoateDrug
Also called Asmanex
220mcg once daily, for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Asmanex | Experimental | Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks. Receives: Drug: Mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention):
Spirometry Body Plethysmography
Measured: 1 Hour
Secondary outcomes (2)
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate
Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post.
Measured: 30 mins, baseline and 8 week post
The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum
We will determine the effects of the inhaled corticosteroid on the cellular profile of sputum. Sputum will be collected and centrifuged, then viewed under a microscope for determination of cellular profile.
Measured: 15 mins during, baseline and 8 week post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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., VA Office of Research and Development
- Investigators
- Miroslav Radulovic, MD, Principal investigator, James J. Peters VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353599
- Sponsor's protocol ID
- 01349
- 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 Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01353599
- Acronym / sponsor ID
- 01349
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Tetraplegia, Pulmonary Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 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)
- First posted
- 13 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.
Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due to complete or partial loss of respiratory muscle innervation which is dependent upon the level and completeness of injury [2]. In addition, they share many aspects of obstructive airway physiology commonly associated with asthma. In asthma, physiological responses such as decrease in baseline airway caliber, bronchodilatation following inhalation of a beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely related to airway inflammation. The cause of such inflammation is unclear, and may be multi-factorial and attributable to: recurrent respiratory infections due to inability to effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional sympathetic innervation to the airways. Therefore, the investigators propose to test for the possible involvement the above mechanisms by pharmacological intervention, and to study effects of such intervention on overall pulmonary function and indirect measures of pulmonary inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile, pulmonary function tests, and cellular profile of the induced sputum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asmanex | Experimental | Drug: Mometasone furoateStudy participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years old; and
- Stable, tetraplegia C3-C8 levels (duration of injury >1 year).
Key exclusion criteria (19 listed)
- Smoking, active or history of smoking during the last six months
- Active respiratory disease(s), such as COPD, inflammatory lung disease, obstructive lung diseases, or acute respiratory infections
- No known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- Ventilator dependence;
- Use of medications known to affect the respiratory system, such as nizoral;
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 |
|---|---|---|
| Mometasone furoateAlso: Asmanex220mcg once daily, for eight weeks | Drug | Asmanex |
Primary outcome
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
Time frame: 1 Hour
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography
2 secondary outcomes
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate
Time frame: 30 mins, baseline and 8 week post
The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum
Time frame: 15 mins during, baseline and 8 week post
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 Mometasone furoate 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 2 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: 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 Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function (time frame: 1 Hour). 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.