Chronic Rhinitis, Nasal Obstruction
Conditions
Keywords
topical intranasal corticosteroid management, nasal airway evaluation, triamcinolone, oxymetazoline
Brief 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.
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.
Interventions
DRUGOxymetazoline + Triamcinolone
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective virtually administered
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
1. Any history of sinonasal mass/tumor 2. Any history of nasal polyps 3. Septal perforation 4. A diagnosis of one of the following conditions: 1. eosinophilic granulomatosis with polyangiitis 2. granulomatosis with polyangiitis 5. Any current intranasal drug use such as cocaine. 6. If they are currently using or have used intranasal steroid medications (oral or nasal) besides oxymetazoline for the past month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate among supratherapeutic users. | week 8 | 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. |
| The rate of partial responders among supratherapeutic users | week 8 | 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. |
| Change in Nasal Obstruction Symptom Evaluation (NOSE) | through study completion, on average of 8 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNyssa Farrell, MD
Washington University School of Medicine
Outcome results
None listed