Clinical trial NCT01353599: Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
Official title: Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Tetraplegia
Pulmonary Function
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Kessler Institute for Rehabilitation
First posted: 2011-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \[2\]. 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.


Eligibility 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).
* History of a milk protein allergy

Primary outcomes:
measure: The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
timeFrame: 1 Hour
Secondary outcomes:
measure: The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate
timeFrame: 30 mins, baseline and 8 week post
measure: The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum
timeFrame: 15 mins during, baseline and 8 week post
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: James J. Peters VA Medical Center
name: Miroslav Radulovic, MD
role: PRINCIPAL_INVESTIGATOR
References: