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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 below
Select...
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 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

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 • NCT01135134
6%
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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications is Mometasone furoate typically prescribed for?

"Mometasone furoate is frequently used for the treatment of dermatitis, eczematous caused by superficial fungal skin infections. This medication can additionally be prescribed to manage conditions like psoriasis, seasonal allergic rhinitis, and cutaneous bacterial illnesses."

Answered by AI

Is this investigation actively recruiting individuals aged sixty and older?

"The requirements for entry into this trial stipulate that participants must be between 18 to 65 years old. Moreover, there are 140 studies open to minors and 737 trials available for seniors."

Answered by AI

Am I eligible to participate in this experiment?

"This research project is in search of 50 individuals aged 18-65 who have sustained a spinal cord injury. To be included, participants must satisfy the following criteria: mature enough to grant consent and not exceeding 65 years old."

Answered by AI

Are there currently any opportunities for patients to participate in this experiment?

"This scientific investigation is not currently accepting candidates, having been initially advertised on August 1st 2011 and last updated October 22nd 2015. Alternately, there are 902 active trials for spinal cord injuries as well as 6 recruiting studies related to Mometasone furoate that participants can explore."

Answered by AI

Is Mometasone furoate generally safe for human consumption?

"As we are in the early stages of testing for Mometasone Furoate, our team at Power has deemed it a 1 on a scale from 1 to 3 due to limited data regarding its safety and efficacy."

Answered by AI

What is the aggregate tally of participants in this research project?

"This medical trial is not available for participation at this time. It was first posted on August 1st 2011, with the most recent update occurring in October of 2015. Currently, there are 902 clinical trials seeking participants with spinal cord injuries and 6 studies recruiting patients to test Mometasone furoate."

Answered by AI

What prior investigations have been conducted into the efficacy of Mometasone furoate?

"Mometasone furoate was first examined in 2006 at Oulu University Hospital's Department of Children and Adolescents. There are presently 119 completed studies, with 6 ongoing trials primarily based in the Bronx, New york City."

Answered by AI
~4 spots leftby Apr 2025