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

This study is ongoing, but not recruiting participants.
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Miroslav Radulovic, M.D., VA Office of Research and Development Identifier:
First received: May 12, 2011
Last updated: October 22, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Spinal Cord Injury
Drug: Mometasone furoate
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Resource links provided by NLM:

Further study details as provided by James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function [ Time Frame: 1 Hour ]

    The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention):

    Spirometry Body Plethysmography

Secondary Outcome Measures:
  • The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate [ Time Frame: 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 [ Time Frame: 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.

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Asmanex


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01353599

United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, New York
James J. Peters VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Institute for Rehabilitation
Principal Investigator: Miroslav Radulovic, MD James J. Peters VA Medical Center
  More Information

Responsible Party: Miroslav Radulovic, M.D., Staff Physician, VA Office of Research and Development Identifier: NCT01353599     History of Changes
Other Study ID Numbers: 01349
Study First Received: May 12, 2011
Last Updated: October 22, 2015

Keywords provided by James J. Peters Veterans Affairs Medical Center:
Spinal Cord Injury
Pulmonary Function

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on May 22, 2017