Decongestants + Steroids for Nasal Obstruction

(STEROID Trial)

Overseen By Sara Kukuljan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must be taking: Topical decongestants

Must not be taking: Intranasal steroids

Disqualifiers: Sinonasal mass, Nasal polyps, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people stop relying on nasal sprays for stuffy noses. Researchers aim to determine if a combination of decongestants (to clear nasal passages) and steroids (such as triamcinolone, to reduce swelling) can better manage symptoms. Participants will gradually reduce their nasal spray use according to a specific plan. Individuals who have experienced chronic stuffy noses and have used decongestant sprays daily for at least three months may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop using any intranasal steroid medications, except for oxymetazoline, if you've used them in the past month.

What prior data suggests that this protocol is safe for nasal obstruction treatment?

Research shows that triamcinolone, a nasal spray, is generally easy to use. Studies have found it safe for children and teenagers. One study showed that a 220-microgram dose daily for two weeks was well-tolerated. Another study found it safe for young children aged 2 to 5, with positive results from a 110-microgram dose once a day. While triamcinolone is safe under a doctor's guidance, users should be aware of possible side effects. Common side effects include a runny or itchy nose and sneezing, especially when used for allergies like hay fever. Always consult a healthcare provider to ensure it is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatment using triamcinolone for nasal obstruction because it combines decongestants with steroids, offering a potentially more comprehensive approach to managing symptoms. Unlike standard treatments that often rely solely on decongestants like oxymetazoline, this approach aims to reduce inflammation with the steroid triamcinolone, which can lead to longer-lasting relief. Additionally, by using a titration schedule to gradually reduce the dependence on decongestants, this method could help minimize the risk of rebound congestion, a common issue with regular decongestant use.

What evidence suggests that this protocol is effective for nasal obstruction?

Research has shown that triamcinolone, a type of steroid, effectively reduces nasal symptoms. In one study, people using triamcinolone nasal spray experienced significant relief from stuffy noses compared to those who did not use it. Another study found that triamcinolone improved daily life for individuals with nasal problems. This treatment has demonstrated the ability to clear up nasal congestion and make breathing more comfortable. In this trial, participants will use triamcinolone as part of their treatment regimen, which may reduce the need for other medications to relieve nasal blockage. ^{6 7 8 9 10}

Who Is on the Research Team?

Nyssa Farrell, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who have been using nasal decongestants daily for at least three months and suffer from chronic nasal obstruction. It's not suitable for those with certain nasal conditions, a history of drug use like cocaine, or recent use of intranasal steroids other than oxymetazoline.

Inclusion Criteria

Ability to read, write, and understand English.

I have been using a nasal spray for congestion daily for over 3 months.

I have a long-term problem with my nose being blocked.

Exclusion Criteria

I have been diagnosed with granulomatosis with polyangiitis.

I have had nasal polyps in the past.

Current intranasal drug use such as cocaine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants follow a titration schedule with oxymetazoline and triamcinolone to eliminate dependence on decongestants

8 weeks

Weekly virtual assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone

Trial Overview The study tests a protocol that gradually reduces the use of topical decongestants (oxymetazoline) while introducing a topical steroid (triamcinolone). The goal is to see if this can help people stop relying on decongestants without worsening their nasal congestion.

How Is the Trial Designed?

Group I: Titration Experimental Treatment 1 Intervention

Participants will begin the trial by providing their average daily usage of oxymetazoline. They will then be stratified according to this usage and placed into a titration schedule. After a week on a given titration level, they will be assessed for severity of nasal obstruction and, if controlled, they will progress to the next lower titration level. Participants with twice daily use, will then be placed in a titration schedule for oxymetazoline concentration which will stop when the oxymetazoline concentration is set to zero.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14582816/

Effects of triamcinolone on quality of life in patients with ... Conclusions: Triamcinolone given for 4 weeks improves symptom scores and HRQL in patients with allergic rhinitis. The ability of triamcinolone to relieve nasal ...

2. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/tri-nasal-triamcinolone-acetonide-nasal-spray-200-and-400-%CE%BCg-qd-v-5/

Tri-nasal triamcinolone acetonide nasal spray 200 and 400 ... A total of 355 patients completed the study. All active treatments were significantly more effective than placebo in relieving nasal symptoms at each treatment ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587604000977

Effect of intranasal triamcinolone acetonide on bronchial ... TANS produced substantial symptomatic recovery in nasal obstruction according to patients' daily diary assessments, and significantly improved all objective ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12869911/

Triamcinolone acetonide aqueous nasal spray and ... Results: Reductions in individual symptoms and total nasal symptom score were statistically significant versus baseline and were equivalent between treatments: ...

5. fda.gov fda.gov/media/71275/download

Triamcinolone Acetonide Statistical Pediatric Review The results of this study showed that NAQ 110mcg QD had statistically significantly greater reduction in the reflective Total Nasal Symptom ...

6. aaaai.org aaaai.org/tools-for-the-public/conditions-library/allergies/triamcinolone-nasal-spray

Over-The-Counter Allergy Nasal Steroid Sprays Although these medicines are safe under a medical provider's care, they do have some potential risks and concerns: 1. Symptoms of allergic rhinitis can be ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/triamcinolone-nasal-route/description/drg-20061212

Triamcinolone (nasal route) - Side effects & dosage Triamcinolone nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by seasonal and perennial hay fever (allergic rhinitis).

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/078104lbl.pdf

Barr Triamcinolone Acetonide Nasal Spray - accessdata.fda.gov The safety and effectiveness of triamcinolone acetonide nasal spray has been evaluated in 518 children 6 to 12 years of age, and 176 adolescents 12 to 17 years ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8885803/

Efficacy and safety of triamcinolone acetonide aqueous ... This study confirmed that a 220-microgram dose of triamcinolone acetonide aqueous nasal spray, administered once daily for 2 weeks, is well tolerated and ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120610603407

Efficacy and safety of triamcinolone acetonide aqueous ... Overall, the results of this study indicate a favorable efficacy and safety profile of TAA AQ, 110 μg once daily, in children aged 2 to 5 years with PAR.