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

Status unconfirmed · Phase 1

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT01353599

Run by

James J. Peters Veterans Affairs Medical Center

People needed

50

Starts

2011-08-01

Last updated by the study team

2015-10-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 65 years old; and
• Stable, tetraplegia C3-C8 levels (duration of injury >1 year).

You may not qualify if…

• 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

Where it is running

• Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.