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

James J. Peters Veterans Affairs Medical Center

Status and phase

Unknown

Phase 1

Conditions

Spinal Cord Injury

Treatments

Drug: Mometasone furoate

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT01353599

01349

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).
History of a milk protein allergy