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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Bronx VA Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bronx VA Medical Center
ClinicalTrials.gov Identifier:
NCT01353599
First received: May 12, 2011
Last updated: May 13, 2011
Last verified: May 2011
  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 parasymphatetic 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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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 Bronx VA 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: 15
Study Start Date: August 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mometasone furoate
    220mcg once daily, for two 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).
  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: Christopher P Renzi, MA 7185849000 ext 3128 christopher.renzi@va.gov

Locations
United States, New York
James J. Peters Dept of Veterans Affairs Medical Center Not yet recruiting
Bronx, New York, United States, 10468
Contact: Miroslav Radulovic, MD    718-584-9000 ext 5472    miroslav.radulovic@va.gov   
Contact: Christopher P Renzi, MA    718-584-9000 ext 3128    christopher.renzi@va.gov   
Sub-Investigator: William Bauman, MD         
Sponsors and Collaborators
Bronx VA Medical Center
Investigators
Principal Investigator: Miroslav Radulovic, MD James J. Peters Dept of Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Miroslav Radulovic, James J. Peters VA Medical Center
ClinicalTrials.gov Identifier: NCT01353599     History of Changes
Other Study ID Numbers: 01349
Study First Received: May 12, 2011
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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 November 25, 2014