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

Phase 1

• Conditions: Spinal Cord Injury
• Interventions: Drug: Mometasone furoate

• Registration Number: NCT01353599
• Lead Sponsor: James J. Peters Veterans Affairs Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Study Start: 2011-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Asmanex	Mometasone furoate	Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function	1 Hour	The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography

Secondary Outcome Measures

Name	Time	Method
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate	30 mins, baseline and 8 week post	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	15 mins during, baseline and 8 week post	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.

Trial Locations

Locations (2)

Kessler Institute for Rehabilitation; 🇺🇸 West Orange, New Jersey, United States

James J. Peters VA Medical Center; 🇺🇸 Bronx, New York, United States