Efficacy and safety of intranasal corticosteroids combined with mucoactive drugs for chronic rhinosinusitis.

BACKGROUND

Chronic rhinosinusitis (CRS) leads to a burden in life and economy. Better therapies need to be explored.

OBJECTIVE

This stage I study aims to explore the efficacy and safety of intranasal corticosteroids combined with mucoactive drugs for CRS.

METHODS

This randomized-controlled, double-blind study was conducted at 13 hospitals from 2021.01.31 to 2023.01.17. CRS patients were randomly assigned into the eucalyptol-limonene-pinene enteric capsules (ELP) group or placebo group, both using budesonide nasal spray (two doses of 64 μg into each nostril twice a day), and followed up at baseline, week 4, and week 8. The difference of Major Symptom Score (MSS) sum score from baseline to week 8 was defined as the primary endpoint.

RESULTS

The data of 291 patients (ELP group: 146 VS. placebo group: 145) were analyzed. The improved mean (SD) of MSS of the budesonide-ELP patients was 4.24 (2.59) at week 4 and 4.37(2.64) at week 8, higher than 3.51(2.27) (Pweek 4 = 0.012) and 3.85 (2.47) (Pweek 8 = 0.093) of budesonide-treated patients, respectively. While, the budesonide-ELP patients had a higher improvement percentage in nasal congestion, postnasal drip, rhinorrhea, and anosmia at week 8 (all P < 0.05). The current clinical control questionnaire in the ELP group significantly differed with placebo group patients at week 4 (P = 0.012), but not at week 8 (P = 0.681). Moreover, the change of Lund-Mackay (LM) and VAS between the two groups was not different at week 8, respectively. However, the CT score of budesonide-ELP-treated patients has significantly improved among smokers at week 8 (P = 0.022).

CONCLUSION

Intranasal corticosteroid combined with mucoactive drugs therapy (budesonide-256 μg/day combined with ELP enteric capsules-0.8 g/day) has the potential to improve subjective symptoms and promote physiological recovery for adult patients with CRS, especially for smokers.