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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Drug: Mometasone furoate

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation
  • New York
    • Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asmanex; Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.	Drug: Mometasone furoate; 220mcg once daily, for eight weeks; Other Names: Asmanex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate	Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post.	30 mins, baseline and 8 week post
The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum	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.	15 mins during, baseline and 8 week post

Collaborators and Investigators

• Sponsor: James J. Peters Veterans Affairs Medical Center
• Collaborators: Kessler Institute for Rehabilitation
• Investigators: Principal Investigator: Miroslav Radulovic, MD, James J. Peters VA Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 12, 2011
• First Posted (Estimate): May 13, 2011

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Pulmonary Function; Spinal Cord Injury; Tetraplegia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: 01349