Budesonide reduces rhinitis symptoms in adults exposed to airborne pollution
Treatment with an intranasal budesonide aqueous spray led to significantly reduced nasal symptoms in adults with rhinitis exposed to high levels of airborne pollution, according to a study presented at AAAAI 2021.
“Consensus statements suggest that intranasal corticosteroids [INSs], such as budesonide, are appropriate treatments for rhinitis symptoms with allergic and nonallergic aetiologies. However, [more clinical data] … are needed to successfully determine the efficacy of INS for the treatment of rhinitis symptoms,” said study author Dr Yuan Zhang from the Department of Otolaryngology Head and Neck Surgery at Beijing TongRen Hospital, Capital Medical University in Beijing, China.
This phase IV, double-blind, placebo-controlled, multicentre trial analysed 206 adults (aged 20–70 years) with moderate-to-severe rhinitis symptoms triggered or worsened by airborne pollution. Subjects were randomized to receive either budesonide 256 µg/day (two 64 µg sprays/nostril) or placebo (n=103 in each group) in the morning for 10 +/- 3 days during the cool season. The primary endpoint of the study was mean change in 24-hour rTNSS*, defined as the sum of severity rating scores for nasal obstruction, secretion/runny nose, and itching/sneezing over the first 10-day treatment period. [AAAAI 2021, abstract L32]
Over the first 10 days, subjects who received budesonide had a significantly greater reduction in rTNSS from baseline (least squares [LS] mean, 2.20 vs 1.72; -38.3 percent vs -29.5 percent; one-sided p=0.01) than those who received placebo.
In addition, those on budesonide achieved a significant improvement in daily itching/sneezing averaged over 10 days (p=0.0009) than those on placebo.
An improvement in daily secretion/runny nose (p=0.078) and nasal obstruction (p=0.067) was also observed among subjects in the budesonide group than the placebo group, but these findings did not reach statistical significance.
However, the budesonide group did not show any improvement in individual non-nasal symptoms of cough or post-natal drip severity (p=0.183 and p=0.079, respectively).
With regard to SGIC** outcome, more subjects in the budesonide group achieved total control of symptoms, as shown by an SGIC score of 4, than those in the placebo group (7.8 percent vs 3.9 percent). However, there was no significant difference in the averaged SGIC between the two groups (LS mean, 2.20 vs 2.35; p=0.105).
“Because statistical significance was not demonstrated for SGIC, all tests for the secondary endpoints were exploratory,” the researchers noted.
“Budesonide 256 µg daily significantly improved nasal symptoms over 10 days in adults with rhinitis triggered or worsened by airborne pollution,” the researchers concluded. “This is the first phase IV study to demonstrate [the] effectiveness of any INS for rhinitis symptom relief during high airborne pollution.”
*rTNSS: Reflective Total Nasal Symptom Score
**SGIC: Subject Global Impression of Change