Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Condition(s) targeted: Spinal Cord Injury

Intervention: Mometasone furoate (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Bronx VA Medical Center

Official(s) and/or principal investigator(s):
Miroslav Radulovic, MD, Principal Investigator, Affiliation: James J. Peters Dept of Veterans Affairs Medical Center

Overall contact:
Miroslav Radulovic, MD, Phone: 7185849000, Ext: 5472, Email: miroslav.radulovic@va.gov

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.

Official title: Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function

Secondary outcome:

The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate

The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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).

Miroslav Radulovic, MD, Phone: 7185849000, Ext: 5472, Email: miroslav.radulovic@va.gov

James J. Peters Dept of Veterans Affairs Medical Center, Bronx, New York 10468, United States; Not yet recruiting
Miroslav Radulovic, MD, Phone: 718-584-9000, Ext: 5472, Email: miroslav.radulovic@va.gov
Christopher P Renzi, MA, Phone: 718-584-9000, Ext: 3128, Email: christopher.renzi@va.gov
William Bauman, MD, Sub-Investigator

Starting date: August 2011
Last updated: May 13, 2011