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Nasal ObstructionPhase 2STEROIDNCT07168148

Steroid Treatment for Elimination of Rebound Obstruction From Intranasal Decongestants

A Phase 2 study testing Oxymetazoline + Triamcinolone in people with Nasal Obstruction and Chronic Rhinitis, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This prospective, virtually administered trial conducted throughout the United States aims to evaluate a standardized protocol including the serial dilution of topical decongestants with concurrent topical steroids (triamcinolone), for elimination of dependence on topical decongestants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Obstruction, Chronic Rhinitis
What is being tested?
Oxymetazoline + Triamcinolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
10 Nov 2025to 19 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 2) have a history of chronic nasal obstruction 3) at least daily topical decongestant usage for at least 3 months 4) ability to read, write, and understand English.

Who cannot join

  • Any history of sinonasal mass/tumor
  • Any history of nasal polyps
  • Septal perforation
  • A diagnosis of one of the following conditions:
  • eosinophilic granulomatosis with polyangiitis
  • granulomatosis with polyangiitis
  • Any current intranasal drug use such as cocaine.
  • If they are currently using or have used intranasal steroid medications (oral or nasal) besides oxymetazoline for the past month.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

This prospective, virtually administered trial conducted throughout the United States aims to evaluate a standardized protocol including the serial dilution of topical decongestants with concurrent topical steroids (triamcinolone), for elimination of dependence on topical decongestants.

Read the detailed description

Participants will begin the trial by providing their average daily usage of oxymetazoline. They will then be stratified according to this usage and will be placed into a titration schedule. In the first week of the trial they will continue their usage of oxymetazoline plus twice daily triamcinolone intranasal spray. Continuing twice daily triamcinolone intranasal spray, the oxymetazoline dosage will be decreased each week until it matches the triamcinolone frequency. Each week following this point the subjects will continue with a mixture of different concentrations of oxymetazoline till complete elimination.

The maximum treatment time for participants who start the trial in the highest frequency oxymetazoline use group (greater than or equal to 5 times per day) would be 8 weeks.

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 titration.

Being tested
Oxymetazoline + Triamcinolone
Keywords
topical intranasal corticosteroid management, nasal airway evaluation, triamcinolone, oxymetazoline
Medical subject headings
Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxymetazoline + TriamcinoloneDrug

    Also called Afrin + Nasacort

    Participants will be stratified according to this usage and placed into a titration schedule.

    • Titration 1: 0.05% 5x/day,
    • Titration 2: 0.05% 4x/day,
    • Titration 3: 0.05 3x/day,
    • Titration 4: 0.05% 2x/day.

    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.

    • Titration 5: 0.0375% Afrin/Nasacort 2x/day,
    • Titration 6: 0.025% Afrin/Nasacort 2x/day,
    • Titration 7: 0.0125% Afrin/Nasacort 2x/day,
    • Titration 8: 0.0% Afrin/Nasacort 2x/day.
Study groups in NCT07168148
Study groupRoleWhat they receive
TitrationExperimentalParticipants 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.
Receives: Drug: Oxymetazoline + Triamcinolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder rate

    The primary outcome measure will be the responder rate, defined as the percentage of participants who are able to discontinue decongestant use by the end of the study period and report that their symptoms are well-controlled, indicated by a score of 4 or less on the CGI-S.

    Measured: week 8

Secondary outcomes (3)

  1. Responder rate among supratherapeutic users.

    Responder rate among supratherapeutic users, will be defined as percentage of participants who started the study using topical decongestants more than twice per day and who are able to discontinue decongestant use by the end of the study period and report that their symptoms are well-controlled, indicated by a score of 4 or less on the CGI-S.

    Measured: week 8

  2. The rate of partial responders among supratherapeutic users

    The rate of partial responders among supratherapeutic users will be defined as the percentage of supratherapeutic users who achieve a reduction in their usage of decongestants to twice daily by the end of the study.

    Measured: week 8

  3. Change in Nasal Obstruction Symptom Evaluation (NOSE)

    NOSE is a disease-specific survey designed to measure nasal obstruction. It consists of 5 questions, each rated on a scale of 0 to 4, and the total score represents the sum of the raw scores multiplied by 5. A score of 30 is considered indicative of clinically significant NAO.

    Change in Nasal Obstruction Symptom Evaluation (NOSE) will be calculated as the difference in NOSE score at baseline minus NOSE score at the end of study participation.

    Measured: through study completion, on average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start10 Nov 2025
  3. Primary completion19 Mar 2026
  4. Study completion19 Mar 2026

Why it stopped: low recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
prospective virtually administered
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168148
Sponsor's protocol ID
202501224
Acronym
STEROID
Status last verified
Mar 2026
First submitted
29 May 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007;19:23-34.

    PubMed 17153005

  • Mehuys E, Gevaert P, Brusselle G, Van Hees T, Adriaens E, Christiaens T, Van Bortel L, Van Tongelen I, Remon JP, Boussery K. Self-medication in persistent rhinitis: overuse of decongestants in half of the patients. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):313-9. doi: 10.1016/j.jaip.2014.01.009. Epub 2014 Mar 29.

    PubMed 24811023

  • LAKE CF. Rhinitis medicamentosa. Proc Staff Meet Mayo Clin. 1946 Sep 18;21(19):367-71. No abstract available.

    PubMed 20274226

  • Feinberg AR, Feinberg SM. The "nose drop nose" due to oxymetazoline (Afrin) and other topical vasoconstrictors. IMJ Ill Med J. 1971 Jul;140(1):50-2. No abstract available.

    PubMed 4104967

  • Hallen H, Enerdal J, Graf P. Fluticasone propionate nasal spray is more effective and has a faster onset of action than placebo in treatment of rhinitis medicamentosa. Clin Exp Allergy. 1997 May;27(5):552-8.

    PubMed 9179430

  • Ferguson BJ, Paramaesvaran S, Rubinstein E. A study of the effect of nasal steroid sprays in perennial allergic rhinitis patients with rhinitis medicamentosa. Otolaryngol Head Neck Surg. 2001 Sep;125(3):253-60. doi: 10.1067/mhn.2001.117717.

    PubMed 11555762

  • Scadding GK. Rhinitis medicamentosa. Clin Exp Allergy. 1995 May;25(5):391-4. doi: 10.1111/j.1365-2222.1995.tb01068.x. No abstract available.

    PubMed 7553240

  • Vaidyanathan S, Williamson P, Clearie K, Khan F, Lipworth B. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010 Jul 1;182(1):19-24. doi: 10.1164/rccm.200911-1701OC. Epub 2010 Mar 4.

    PubMed 20203244

  • Graedon, Terry. "How to Beat Nose Spray Dependence One Nostril at a Time." Https://Www.Peoplespharmacy.Com/, The People's Pharmacy, 27 Mar. 2023, www.peoplespharmacy.com/articles/how-to-beat-nose-spray-dependence-one- nostril-at-a-time.

  • Afrin Addicts. [ca. 2024]. In Facebook [Group page]. Retrieved September 4, 2024, from https://www.facebook.com/groups/1551311815137595

  • Park SSE, Barmettler A. Vision Loss Secondary to Facial and Periorbital Steroid Injection: A Systematic Review. Ophthalmic Plast Reconstr Surg. 2021 Nov-Dec 01;37(6):511-521. doi: 10.1097/IOP.0000000000001910.

    PubMed 33481540

  • Elwany SS, Stephanos WM. Rhinitis medicamentosa. An experimental histopathological and histochemical study. ORL J Otorhinolaryngol Relat Spec. 1983;45(4):187-94. doi: 10.1159/000275642.

    PubMed 6192384

  • Elwany S, Abdel-Salaam S. Treatment of rhinitis medicamentosa with fluticasone propionate--an experimental study. Eur Arch Otorhinolaryngol. 2001 Mar;258(3):116-9. doi: 10.1007/s004050000309.

    PubMed 11374251

  • Knipping S, Holzhausen HJ, Goetze G, Riederer A, Bloching MB. Rhinitis medicamentosa: electron microscopic changes of human nasal mucosa. Otolaryngol Head Neck Surg. 2007 Jan;136(1):57-61. doi: 10.1016/j.otohns.2006.08.025.

    PubMed 17210334

  • Lin CY, Cheng PH, Fang SY. Mucosal changes in rhinitis medicamentosa. Ann Otol Rhinol Laryngol. 2004 Feb;113(2):147-51. doi: 10.1177/000348940411300213.

    PubMed 14994772

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxymetazoline + Triamcinolone in people with Nasal Obstruction and Chronic Rhinitis, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate (time frame: week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168148, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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