Intranasal Steroids and Oxymetazoline in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis
      medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to
      faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of
      fluticasone furoate alone.
    

Detailed description: 
      We performed a 6-week, 4-group, parallel, randomized, double-blind, double-dummy, clinical
      trial in 60 patients with perennial allergic rhinitis. After an initial screening with an
      allergy questionnaire and skin puncture testing to confirm an allergic response to a
      perennial allergen (cat, dog, dust mite, indoor mold), qualified individuals were randomized
      into 1 of 4 treatment groups. The 4 groups received the following treatments: placebo, OXY
      (0.05%, 2 puffs in each nostril every evening), FF nasal spray (110 mg per day), and FF nasal
      spray plus OXY (FF/OXY). All participants received 2 nasal sprays at night, with 1 spray
      containing FF or its placebo, the other oxymetazoline or its placebo. The nasal sprays were
      labeled with participant code numbers, and the investigator assigned participants in a
      sequential randomized fashion to a study code number in blocks of 4. Dropouts were replaced
      until 60 subjects were randomized. Replacement subjects were assigned the next sequential
      treatment. Thus, the number of subjects in each group was not exactly 15.

      Eligible participants completed the Rhinitis Quality of Life Questionnaire (RQLQ) and
      underwent measurement of nasal volume by acoustic rhinometry before starting the study.
      Participants were instructed to keep a diary of daily symptoms, nasal peak inspiratory flow
      (NPIF) meter readings, and medication use during the study; no rescue medications were
      allowed. The severity of sneezing, rhinorrhea, nasal congestion, and other symptoms was
      recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime
      symptoms) on a 0 to 3 scale. Intake of the study medication was performed once daily, at
      night, after recording of symptoms and NPIF values. Subjects returned to the nasal laboratory
      every 2 weeks for a total of 4 weeks for review of the symptom diaries, replacement of
      medications, performance of acoustic rhinometry, and completion of the RQLQ. After the fourth
      week, participants stopped treatment, returned medication, and continued with the clinical
      trial for 2 additional weeks. During this time, they maintained symptom diaries and NPIF
      measurements twice daily. At the end of the 2-week period, participants returned to the nasal
      laboratory to perform a final acoustic rhinometry, complete an RQLQ survey, and return the
      diaries.
    

Intervention name(s): Fluticasone furoate; Placebo Fluticasone furoate; Oxymetazoline; Placebo Oxymetazoline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm; 2 puffs of each nasal spray in each nostril in the pm
Other intervention name(s): Veramyst; Oxymetazoline hydrochloride
Intervention MeSH terms: Fluticasone; Xhance; Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment