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Corticosteroid

Inhaled Steroids for Spinal Cord Injury

Phase 1
Waitlist Available
Led By Miroslav Radulovic, MD
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 65 years old
Stable tetraplegia at C3-C8 levels with duration of injury greater than 1 year
Must not have
Adrenal insufficiency as indicated in the patient medical record
History of glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 mins, baseline and 8 week post
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial will test the effects of pharmacological intervention on individuals with chronic cervical SCI who share many aspects of obstructive airway physiology commonly associated with asthma.

Who is the study for?
This trial is for adults aged 18-65 with stable tetraplegia at C3-C8 levels from a spinal cord injury that happened over a year ago. It's not for smokers, those with active lung diseases or asthma, people dependent on ventilators, or those taking certain medications affecting the respiratory system.
What is being tested?
The trial tests Mometasone furoate's effects on pulmonary function in individuals with chronic cervical SCI. It aims to see if this treatment can improve breathing by reducing airway inflammation measured through various lung function tests and biomarkers.
What are the potential side effects?
Mometasone furoate may cause side effects like sore throat, nosebleeds, headache, upper respiratory infections, sinusitis and it might affect adrenal gland function. Long-term use could lead to cataracts or glaucoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have had stable paralysis in my limbs due to a neck injury for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My medical records show I have adrenal insufficiency.
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I have a history of glaucoma.
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I have an active lung condition like COPD or asthma.
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I have a history of cataracts.
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I am able to understand and make decisions about my health care.
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My medical records show I have heart or artery disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 mins, baseline and 8 week post
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 mins, baseline and 8 week post for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
Secondary study objectives
The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum
The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate

Side effects data

From 2010 Phase 3 trial • 333 Patients • NCT01135134
6%
Epistaxis
5%
Naspharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
MFNS

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AsmanexExperimental Treatment1 Intervention
Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mometasone furoate
FDA approved

Find a Location

Who is running the clinical trial?

Kessler Institute for RehabilitationIndustry Sponsor
22 Previous Clinical Trials
1,115 Total Patients Enrolled
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,830 Total Patients Enrolled
Miroslav Radulovic, MDPrincipal InvestigatorJames J. Peters VA Medical Center
3 Previous Clinical Trials
99 Total Patients Enrolled

Media Library

Mometasone furoate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT01353599 — Phase 1
Spinal Cord Injury Research Study Groups: Asmanex
Spinal Cord Injury Clinical Trial 2023: Mometasone furoate Highlights & Side Effects. Trial Name: NCT01353599 — Phase 1
Mometasone furoate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01353599 — Phase 1
~4 spots leftby Nov 2025
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