Safety and efficacy of novel mometasone furoate nasal spray in acute rhinosinusitis patients

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Created On: 04/02/2023

A randomized clinical trial aimed to compare the safety and effectiveness of mometasone furoate nano-nasal spray (MF-NNS) with mometasone furoate nasal spray (MFNS) to treat allergic rhinitis.

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Key take away

Mometasone furoate nano-nasal spray was considerably more effective than mometasone furoate nasal spray in alleviating rhinitis symptoms in people aged 10-50 years.

Background

A randomized clinical trial aimed to compare the safety and effectiveness of mometasone furoate nano-nasal spray (MF-NNS) with mometasone furoate nasal spray (MFNS) to treat allergic rhinitis.

Method

Overall, 20 subjects (10-50 years old) were enrolled. Ten patients each were assigned to the MFNS group and MF-NNS group and were administered 50 mcg MFNS and MF-NNS doses, respectively. For a 3-week effectiveness and safety phase, this regimen was given as a nasal spray.

Mean alteration in the doctor-evaluated total nasal symptom score (TNSS) from baseline to day 21 served as the study's major efficacy outcome. Other effectiveness factors in the phase were the total symptom score (TSS, non-nasal and nasal symptoms, summed), individual nasal symptoms, and subject-evaluated TNSS. Recording of adverse events was done.

Result

Between the two groups, clinical and demographic traits were similar. In comparison to MFNS subjects, MF-NNS subjects had a profound decrease in the symptoms endpoint of doctor-assessed alteration in TNSS from baseline to day 21. Similarly, considerable enhancements were seen in MF-NNS. Those patients who took MF-NNS for 21 days showed greater enhancements. At baseline, those receiving MF-NNS had considerably better overall rhinitis compared to those receiving MFNS.

The overall condition of rhinitis as determined by the physician continued to improve across the course of the trial for both groups. Furthermore, as therapy continued, the degree of improvement elevated. The MFNS and MF-NNS groups experienced similar numbers of adverse events. Most of the adverse events were noted to be unrelated to therapy and were of mild or moderate severity.

Conclusion

MF-NSS 50-µg doses administered once daily decreases nasal symptoms like congestion and nasal blockage, making it an effective and well-tolerated therapy for seasonal rhinitis in both children and adults.