Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
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Purpose
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 parasymphatetic 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Drug: Mometasone furoate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury |
- The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function [ Time Frame: 1 Hour ] [ Designated as safety issue: No ]
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention):
Spirometry Body Plethysmography
- The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate [ Time Frame: 30 mins, baseline and 8 week post ] [ Designated as safety issue: No ]Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post.
- The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum [ Time Frame: 15 mins during, baseline and 8 week post ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
-
Drug: Mometasone furoate
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 65 years old; and
- Stable, tetraplegia C3-C8 levels (duration of injury >1 year).
Exclusion Criteria:
- 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
- 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).
Contacts and Locations| Contact: Miroslav Radulovic, MD | 7185849000 ext 5472 | miroslav.radulovic@va.gov |
| Contact: Christopher P Renzi, MA | 7185849000 ext 3128 | christopher.renzi@va.gov |
| United States, New York | |
| James J. Peters Dept of Veterans Affairs Medical Center | Not yet recruiting |
| Bronx, New York, United States, 10468 | |
| Contact: Miroslav Radulovic, MD 718-584-9000 ext 5472 miroslav.radulovic@va.gov | |
| Contact: Christopher P Renzi, MA 718-584-9000 ext 3128 christopher.renzi@va.gov | |
| Sub-Investigator: William Bauman, MD | |
| Principal Investigator: | Miroslav Radulovic, MD | James J. Peters Dept of Veterans Affairs Medical Center |
More Information
No publications provided
| Responsible Party: | Miroslav Radulovic, James J. Peters VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01353599 History of Changes |
| Other Study ID Numbers: | 01349 |
| Study First Received: | May 12, 2011 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013