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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Washington University
St Louis, Missouri, United States
RECRUITINGResponder 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.
Time frame: week 8
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.
Time frame: week 8
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.
Time frame: week 8
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.
Time frame: through study completion, on average of 8 weeks
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