The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to determine if intranasal corticosteroids have an effect on
      nasal obstruction in patients with nasal septal deviation.
    

Detailed description: 
      Participants were identified at their initial visit to the Stanford Facial Plastic and
      Reconstructive Surgery Clinic, an academic referral center, in consultation for nasal
      obstruction. If eligible and interested in participating, patients provided written informed
      consent prior to randomization.

      Eligible participants were patients over the age of 18 years of age with the presence of
      nasal septal deviation as identified by physical examination, as well as a baseline NOSE
      score of 35 or greater. Exclusion criteria included a history of nasal or septal surgery, use
      of intranasal steroids in the three months preceding enrollment, use of systemic steroids in
      the six months preceding enrollment, and pregnancy or active breastfeeding at the time of
      enrollment. In order to maximize generalizability of the study, no medications other than
      systemic and intranasal steroids were used as exclusion criteria.

      All study participants received 6 weeks of therapy with an intranasal steroid spray, Nasacort
      (Chattem Inc), which consists of the steroid triamcinolone acetonide, as well as 6 weeks of
      placebo with Ayr saline spray (B.F. Ascher). These two study drugs were packaged identically
      by a local pharmacist and labelled Drug A and Drug B. Nasacort was selected as the intranasal
      steroid following pharmacist consultation, as this intranasal steroid is less scented than
      others and therefore was less likely to be distinguishable from the placebo to participants.
      Participants were instructed to use both drugs as follows: 1 spray per nostril twice a day.
      Researchers, statistical analysts, and study participants were blinded to the identity of the
      two drugs until the conclusion of the study. A duration of 6 weeks per drug was selected
      based on the most commonly observed insurance requirements seen in our practice. Following
      unblinding, it was determined that Drug A was the placebo, the saline spray, and Drug B was
      the test drug, the nasal steroid.

      Following completion of both study drugs, patients were offered surgical intervention. If
      interested and medically cleared for surgery, patients underwent surgery. All surgeries were
      performed by the senior author and included open septorhinoplasty to address septal
      deviation, with repair of nasal valve stenosis and inferior turbinate reduction performed in
      some patients as deemed necessary by the senior author.
    

Intervention name(s): Triamcinolone Acetonide; Ayr saline nasal mist
Intervention type(s): Drug; Drug
Intervention description(s): 2 sprays sprayed to both nostrils daily for 42 days.; 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
Other intervention name(s): Nasacort
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment