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

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mometasone furoate
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Tetraplegia, Pulmonary Function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Institute for Rehabilitation
  • James J. Peters VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Asmanex

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 12, 2011
Last Updated
October 22, 2015
Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT01353599
Brief Title
Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
Official Title
Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center
Collaborators
Kessler Institute for Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury, Tetraplegia, Pulmonary Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asmanex
Arm Type
Experimental
Arm Description
Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate
Other Intervention Name(s)
Asmanex
Intervention Description
220mcg once daily, for eight weeks
Primary Outcome Measure Information:
Title
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
Description
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography
Time Frame
1 Hour
Secondary Outcome Measure Information:
Title
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate
Description
Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post.
Time Frame
30 mins, baseline and 8 week post
Title
The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum
Description
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.
Time Frame
15 mins during, baseline and 8 week post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Radulovic, MD
Organizational Affiliation
James J. Peters VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
James J. Peters VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

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

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