NCT01353599

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

4.6 years

First QC Date

May 12, 2011

Last Update Submit

October 22, 2015

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryTetraplegiaPulmonary Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate

    30 mins, baseline and 8 week post

  • The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum

    15 mins during, baseline and 8 week post

Study Arms (1)

Asmanex

EXPERIMENTAL

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

Drug: Mometasone furoate

Interventions

Mometasone furoateDRUG

220mcg once daily, for eight weeks

Also known as: Asmanex
Asmanex

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old; and
  • Stable, tetraplegia C3-C8 levels (duration of injury \>1 year).

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesQuadriplegia

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Miroslav Radulovic, MD

    James J. Peters VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 13, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2016

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

US(2)