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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 mins, baseline and 8 week post
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 65 years old.
Select...
I have had stable paralysis in my limbs due to a neck injury for over a year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 mins, baseline and 8 week post
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 mins, baseline and 8 week post
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
Secondary outcome measures
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 • NCT011351346%
Epistaxis
5%
Naspharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
MFNS
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
2,850 Total Patients Enrolled
Miroslav Radulovic, MDPrincipal InvestigatorJames J. Peters VA Medical Center
3 Previous Clinical Trials
99 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medical records show I have adrenal insufficiency.I have a history of glaucoma.I have a pressure ulcer or a wound that healed within the last 3 months.You have had an allergy to milk protein in the past.I have an active lung condition like COPD or asthma.I am not taking medications that affect my breathing or interact with mometasone.I have never had asthma and no recent respiratory infections.I have a history of cataracts.I am between 18 and 65 years old.I have had stable paralysis in my limbs due to a neck injury for over a year.You have smoked or been around smoke in the past six months.I am able to understand and make decisions about my health care.My medical records show I have heart or artery disease.You rely on a ventilator for breathing.You have high blood pressure with a starting blood pressure of 140/90 mmHg or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Asmanex
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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