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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by James J. Peters Veterans Affairs Medical Center
Sponsor:
Collaborator:
Kessler Institute for Rehabilitation
Information provided by (Responsible Party):
Miroslav Radulovic, M.D., Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01353599
First received: May 12, 2011
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353599

Contacts
Contact: Miroslav Radulovic, MD 7185849000 ext 5472 miroslav.radulovic@va.gov
Contact: Joshua Hobson, MS 7185849000 ext 3129 joshua.hobson@va.gov

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Christopher Cirnigliaro, MS    973-731-3900 ext 2755    christopher.cirgnigliaro@va.gov   
Contact: Frank Azarelo, MS    9737313900 ext 2755    frank.azarelo@va.gov   
Sub-Investigator: Christopher Cirnigliaro, MS         
United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Miroslav Radulovic, MD    718-584-9000 ext 5472    miroslav.radulovic@va.gov   
Contact: Joshua Hobson, MS    718-584-9000 ext 3129    joshua.hobson@va.gov   
Sub-Investigator: William Bauman, MD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Kessler Institute for Rehabilitation
Investigators
Principal Investigator: Miroslav Radulovic, MD James J. Peters VA Medical Center
  More Information

No publications provided

Responsible Party: Miroslav Radulovic, M.D., Staff Physician, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01353599     History of Changes
Other Study ID Numbers: 01349
Study First Received: May 12, 2011
Last Updated: March 30, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015