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Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis. (TJ-50-E-2017-1)

Chronic Sinusitis and TJ-50 (TJ-50-E-2017-1)

25

In the standard treatment group, the median age is 51 years old (24-76 years old), height is 164.02 +- 12.51 cm, weight is 64.75 +- 15.29 kg, and severity (CT) is 4.8 +- 3.2 for the left nose and 5.8 +- 2.9 for the right nose. There are 7 males and 6 females in the standard treatment group. In the TJ-50 combination group, the median age is 54 years (32-70 years), height is 168.44 +- 6.37 cm, weight is 78.83 +- 12.12 kg, and severity (CT) is 7.0 +- 3.5 for the left nose and is 5.2 +- 4.1 for the right nose. There are 8 males and 1 female in the TJ-50 combination group.

The number of patients who completed the administration of the study drug at Visit 4, the end of observation, was 22 out of 25. The reasons and breakdown of discontinuations were as follows: 1 case of withdrawal of consent in the TJ-50 combination group, and 2 cases in which it was found before allocation that the observation could not be completed within the observation period of the protocol. Regarding the enrollment status, from September 2018 to January 2019, there was an average of about one case enrolled per month, and from February to May 2019, there were no enrollments. Thereafter, from June to September 2019, there was an average of about 2 to 3 cases registered per month, but the target number of cases could not be reached within the study period.

The incidence of adverse events was 1 in the standard treatment group (7.7%) and 1 in the TJ-50 combination group (11.1%). The main adverse events were intranasal infection in 1 patient (standard treatment group) and urticaria in 1 patient (TJ-50 combination group). There were no serious adverse events in either group. In addition, side effect was not observed.

In this study, the primary endpoint of efficacy is the patient QOL questionnaire (SNOT-22) and the effect of each group was verified. As a result, the total score change from before admission to discharge was -7.8 +- 20.4 in the standard treatment group and -1.16 +- 10.9 in the TJ-50 combination group, showing no significant difference between the two groups ( p = 0.562). In Visit 1, the change in total score from before admission was -17.8 +- 13.1 in the standard treatment group and -5.67 +- 12.5 in the TJ-50 combination group, showing a significant improvement in the standard treatment group (p = 0.04). In Visit2, the change was 18.2 +- 16.4 in the standard treatment group and -13.4 +- 14.1 in the TJ-50 combination group, showing no significant difference between the two groups (p = 0.327). In Visit3, the change was -23.0 +- 13.8 in the standard treatment group and -15.0 +- 14.4 in the TJ-50 combination group, showing no significant difference between the two groups (p = 0.364). In Visit4, the change was -23.3 +- 15.5 in the standard treatment group and -17.4 +- 12.5 in the TJ-50 combination group, showing no significant difference between the two groups (p = 0.467). Secondary endpoints are clinical laboratory test values(WBC, WBC differentiation (neutrophils, eosinophils, basophils, lymphocytes, monocytes)), the composition rate of each bacterium with and without CAM, the CAM resistance rate of each bacterium with and without CAM, the frequency of detection of CAM-resistant bacteria with and without CAM, the score of Baba et al., And the olfactory survey (VAS). However, no significant difference was observed in these endpoints between the two groups.

In this study comparing the efficacy and safety of the conventional treatment group and the TJ-50 group for postoperative chronic sinusitis, there was no significant difference between the two groups in the total change in the total score of Visit 4 from before admission. In addition, no side effects were observed in either group. Although the superiority of the TJ-50 combination group could not be demonstrated in this study, it is considered as a treatment option for postoperative chronic sinusitis.

Feb. 28, 2022

Aug. 02, 2023

https://onlinelibrary.wiley.com/doi/full/10.1002/tkm2.1384

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180048

Hatakeyama Hiromitsu

Yokohama City University Medical Center

4-57 Urafune-cho,Minami-ku Yokohama, JAPAN

htkym@yokohama-cu.ac.jp

Hatakeyama Hiromitsu

Yokohama city university medical center

4-57 Urafune-cho,Minami-ku Yokohama, JAPAN

+81-45-261-5656

htkym@yokohama-cu.ac.jp

Complete

May. 08, 2018

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1) The patient is diagnosed with chronic sinusitis 2) The patient is planned treatment by ESS(Endoscopic Sinus Surgery) 3) The patient can be treated with long-term, low-dose macrolide. 4) 20 to 80 years old 5) Both gender6)Written informed consent of this study is obtained from the patient

1) The patients scheduled to undergo surgical procedures other than ESS as a treatment for chronic sinusitis 2) The patients suspected of typical eosinophilic sinusitis 3) The patients complicated of aspirin asthma 4) The patients complicated with bronchial asthma 5) The patients complicated of NSAIDs allergy 6) Pregnant women, lactating women, and patients who have the possibility or intention of pregnancy 7) The patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study 8) The patients judged unsuitable by researchers

Both

Chronic Sinusitis

We aim to investigate on efficacy and safety of TJ-50 for the patient who diagnosed with chronic sinusitis and received endoscopic sinus surgery. This study was an open-label randomized trial between the groups who treated with TJ-50 or not after ESS.

A score of the QOL by the patient using SNOT-22 at 3 months after the ESS

1) Nasal mucosal findings (Baba's score) 2) Colony Forming Unit (CFU) in the nasal cavity 3) Olfactory survey (VAS) 4) Laboratory test values (WBC, leukocyte fraction (neutrophils, eosinophils, basophils, lymphocytes, monocytes))

+81-45-370-7627

Oct. 05, 2018

none