Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

Hiroyuki Kobayashi; Hiroaki Takeda; Susumu Sakayori; Akira Saito; Ichiro Nakayama; Masumi Tomizawa; Yohmei Hiraga; Mitsuhide Ohmichi; Kenji Kataoka; Masashi Tamura; Kazuo Obara; Kazuki Konishi; Hitoshi Kobayashi; Akira Watanabe; Shigeo Takizawa; Mikae Nakamura; Kaoru Shimada; Yasuyuki Sano; Yasufumi Miyamoto; Norio Kikuchi; Osamu Sakai; Koya Shiba; Shinichi Tanimoto; Koichiro Nakata; Tatsuo Nakatani; Harumi Shishido; Hideaki Nagai; Jingoro Shimada; Seiji Hori; Fumio Matsumoto; Takeo Imai; Shigeki Odagiri; Hiroshi Takahashi; Kenichi Takahashi; Yoshihiro Hirai; Akira Syoji; Takashi Sakuma; Takao Okubo; Hirotada Ikeda; Masaaki Arakawa; Koichi Wada; Fumihide Iwata; Nobuki Aoki; Osamu Sekine; Yasutoshi Suzuki; Teruya Yoshimi; Atsuhiko Sato; Kingo Chida; Takafumi Suda; Atsushi Yoshitomi; Takeshi Yagi; Toshihiko Takeuchi; Hidekazu Hanaki; Yasuo Yamada; Nobuhiro Narita; Masayoshi Sawaki; Keiichi Mikasa; Fumio Miki; Rinzo Soejima; Niro Okimoto; Yoshihito Niki; Toshiharu Matsushima; Makoto Kimura; Michio Yamakido; Kenji Hasegawa; Kotaro Oizumi; Yoichiro Ichikawa; Naoto Tokunaga; Takeshi Araki; Kazuma Fujino; Kohei Hara; Shigeru Kohno; Mitsuo Kaku; Hironobu Koga; Naomi Ito; Keizo Matsumoto; Masakazu Takasugi; Hiroshi Watanabe; Masaru Nasu; Yoichiro Goto; Tohru Yamasaki; Jun Goto; Kazuo Kitagawa; Atsushi Saito; Yuei Irabu; Mitsuyoshi Nakashima; Koichi Deguchi

Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

Hiroyuki Kobayashi, Hiroaki Takeda, Susumu Sakayori, Akira Saito, Ichiro Nakayama, Masumi Tomizawa, Yohmei Hiraga, Mitsuhide Ohmichi, Kenji Kataoka, Masashi Tamura, Kazuo Obara, Kazuki Konishi, Hitoshi Kobayashi, Akira Watanabe, Shigeo Takizawa, Mikae Nakamura, Kaoru Shimada, Yasuyuki Sano, Yasufumi Miyamoto, Norio KikuchiOsamu Sakai, Koya Shiba, Shinichi Tanimoto, Koichiro Nakata, Tatsuo Nakatani, Harumi Shishido, Hideaki Nagai, Jingoro Shimada, Seiji Hori, Fumio Matsumoto, Takeo Imai, Shigeki Odagiri, Hiroshi Takahashi, Kenichi Takahashi, Yoshihiro Hirai, Akira Syoji, Takashi Sakuma, Takao Okubo, Hirotada Ikeda, Masaaki Arakawa, Koichi Wada, Fumihide Iwata, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Teruya Yoshimi, Atsuhiko Sato, Kingo Chida, Takafumi Suda, Atsushi Yoshitomi, Takeshi Yagi, Toshihiko Takeuchi, Hidekazu Hanaki, Yasuo Yamada, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Fumio Miki, Rinzo Soejima, Niro Okimoto, Yoshihito Niki, Toshiharu Matsushima, Makoto Kimura, Michio Yamakido, Kenji Hasegawa, Kotaro Oizumi, Yoichiro Ichikawa, Naoto Tokunaga, Takeshi Araki, Kazuma Fujino, Kohei Hara, Shigeru Kohno, Mitsuo Kaku, Hironobu Koga, Naomi Ito, Keizo Matsumoto, Masakazu Takasugi, Hiroshi Watanabe, Masaru Nasu, Yoichiro Goto, Tohru Yamasaki, Jun Goto, Kazuo Kitagawa, Atsushi Saito, Yuei Irabu, Mitsuyoshi Nakashima, Koichi Deguchi

Research output: Contribution to journal › Article › peer-review

Abstract

A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200 mg q. d. (Group L) were compared with GPFX 300 mg q. d. (Group H) by the double-blind method, and each dose of GPFX was compared with open-label treatment with OFLX 200 mg t. i. d. (Group 0). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group 0) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2% (33/37), 97.6% (40/41), and 88.4% (38/43) in Groups L, H, and 0, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0% (15/20), 93.3% (14/15), and 85.7% (18/21) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and 0, the incidence of adverse reactions was 2.6% (1/39), 7.3% (3/41) and 9.1% (4/44), respectively, and the incidence of abnormal laboratory findings was 5.1% (2/39), 5.1% (2/39), and 4.9% (2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5% (32/37), 94.9% (37/39), and 85.4% (35/41) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300 mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.

Original language	English
Pages (from-to)	439-441
Number of pages	3
Journal	Japanese Journal of Chemotherapy
Volume	45
Issue number	6
Publication status	Published - 1997
Externally published	Yes

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

Cite this

Kobayashi, H., Takeda, H., Sakayori, S., Saito, A., Nakayama, I., Tomizawa, M., Hiraga, Y., Ohmichi, M., Kataoka, K., Tamura, M., Obara, K., Konishi, K., Kobayashi, H., Watanabe, A., Takizawa, S., Nakamura, M., Shimada, K., Sano, Y., Miyamoto, Y., ... Deguchi, K. (1997). Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection. Japanese Journal of Chemotherapy, 45(6), 439-441.

Kobayashi, H, Takeda, H, Sakayori, S, Saito, A, Nakayama, I, Tomizawa, M, Hiraga, Y, Ohmichi, M, Kataoka, K, Tamura, M, Obara, K, Konishi, K, Kobayashi, H, Watanabe, A, Takizawa, S, Nakamura, M, Shimada, K, Sano, Y, Miyamoto, Y, Kikuchi, N, Sakai, O, Shiba, K, Tanimoto, S, Nakata, K, Nakatani, T, Shishido, H, Nagai, H, Shimada, J, Hori, S, Matsumoto, F, Imai, T, Odagiri, S, Takahashi, H, Takahashi, K, Hirai, Y, Syoji, A, Sakuma, T, Okubo, T, Ikeda, H, Arakawa, M, Wada, K, Iwata, F, Aoki, N, Sekine, O, Suzuki, Y, Yoshimi, T, Sato, A, Chida, K, Suda, T, Yoshitomi, A, Yagi, T, Takeuchi, T, Hanaki, H, Yamada, Y, Narita, N, Sawaki, M, Mikasa, K, Miki, F, Soejima, R, Okimoto, N, Niki, Y, Matsushima, T, Kimura, M, Yamakido, M, Hasegawa, K, Oizumi, K, Ichikawa, Y, Tokunaga, N, Araki, T, Fujino, K, Hara, K, Kohno, S, Kaku, M, Koga, H, Ito, N, Matsumoto, K, Takasugi, M, Watanabe, H, Nasu, M, Goto, Y, Yamasaki, T, Goto, J, Kitagawa, K, Saito, A, Irabu, Y, Nakashima, M & Deguchi, K 1997, 'Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection', Japanese Journal of Chemotherapy, vol. 45, no. 6, pp. 439-441.

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abstract = "A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200 mg q. d. (Group L) were compared with GPFX 300 mg q. d. (Group H) by the double-blind method, and each dose of GPFX was compared with open-label treatment with OFLX 200 mg t. i. d. (Group 0). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group 0) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2% (33/37), 97.6% (40/41), and 88.4% (38/43) in Groups L, H, and 0, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0% (15/20), 93.3% (14/15), and 85.7% (18/21) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and 0, the incidence of adverse reactions was 2.6% (1/39), 7.3% (3/41) and 9.1% (4/44), respectively, and the incidence of abnormal laboratory findings was 5.1% (2/39), 5.1% (2/39), and 4.9% (2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5% (32/37), 94.9% (37/39), and 85.4% (35/41) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300 mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.",

author = "Hiroyuki Kobayashi and Hiroaki Takeda and Susumu Sakayori and Akira Saito and Ichiro Nakayama and Masumi Tomizawa and Yohmei Hiraga and Mitsuhide Ohmichi and Kenji Kataoka and Masashi Tamura and Kazuo Obara and Kazuki Konishi and Hitoshi Kobayashi and Akira Watanabe and Shigeo Takizawa and Mikae Nakamura and Kaoru Shimada and Yasuyuki Sano and Yasufumi Miyamoto and Norio Kikuchi and Osamu Sakai and Koya Shiba and Shinichi Tanimoto and Koichiro Nakata and Tatsuo Nakatani and Harumi Shishido and Hideaki Nagai and Jingoro Shimada and Seiji Hori and Fumio Matsumoto and Takeo Imai and Shigeki Odagiri and Hiroshi Takahashi and Kenichi Takahashi and Yoshihiro Hirai and Akira Syoji and Takashi Sakuma and Takao Okubo and Hirotada Ikeda and Masaaki Arakawa and Koichi Wada and Fumihide Iwata and Nobuki Aoki and Osamu Sekine and Yasutoshi Suzuki and Teruya Yoshimi and Atsuhiko Sato and Kingo Chida and Takafumi Suda and Atsushi Yoshitomi and Takeshi Yagi and Toshihiko Takeuchi and Hidekazu Hanaki and Yasuo Yamada and Nobuhiro Narita and Masayoshi Sawaki and Keiichi Mikasa and Fumio Miki and Rinzo Soejima and Niro Okimoto and Yoshihito Niki and Toshiharu Matsushima and Makoto Kimura and Michio Yamakido and Kenji Hasegawa and Kotaro Oizumi and Yoichiro Ichikawa and Naoto Tokunaga and Takeshi Araki and Kazuma Fujino and Kohei Hara and Shigeru Kohno and Mitsuo Kaku and Hironobu Koga and Naomi Ito and Keizo Matsumoto and Masakazu Takasugi and Hiroshi Watanabe and Masaru Nasu and Yoichiro Goto and Tohru Yamasaki and Jun Goto and Kazuo Kitagawa and Atsushi Saito and Yuei Irabu and Mitsuyoshi Nakashima and Koichi Deguchi",

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language = "English",

volume = "45",

pages = "439--441",

journal = "Japanese Journal of Chemotherapy",

issn = "1340-7007",

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T1 - Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

AU - Kobayashi, Hiroyuki

AU - Takeda, Hiroaki

AU - Sakayori, Susumu

AU - Saito, Akira

AU - Nakayama, Ichiro

AU - Tomizawa, Masumi

AU - Hiraga, Yohmei

AU - Ohmichi, Mitsuhide

AU - Kataoka, Kenji

AU - Tamura, Masashi

AU - Obara, Kazuo

AU - Konishi, Kazuki

AU - Kobayashi, Hitoshi

AU - Watanabe, Akira

AU - Takizawa, Shigeo

AU - Nakamura, Mikae

AU - Shimada, Kaoru

AU - Sano, Yasuyuki

AU - Miyamoto, Yasufumi

AU - Kikuchi, Norio

AU - Sakai, Osamu

AU - Shiba, Koya

AU - Tanimoto, Shinichi

AU - Nakata, Koichiro

AU - Nakatani, Tatsuo

AU - Shishido, Harumi

AU - Nagai, Hideaki

AU - Shimada, Jingoro

AU - Hori, Seiji

AU - Matsumoto, Fumio

AU - Imai, Takeo

AU - Odagiri, Shigeki

AU - Takahashi, Hiroshi

AU - Takahashi, Kenichi

AU - Hirai, Yoshihiro

AU - Syoji, Akira

AU - Sakuma, Takashi

AU - Okubo, Takao

AU - Ikeda, Hirotada

AU - Arakawa, Masaaki

AU - Wada, Koichi

AU - Iwata, Fumihide

AU - Aoki, Nobuki

AU - Sekine, Osamu

AU - Suzuki, Yasutoshi

AU - Yoshimi, Teruya

AU - Sato, Atsuhiko

AU - Chida, Kingo

AU - Suda, Takafumi

AU - Yoshitomi, Atsushi

AU - Yagi, Takeshi

AU - Takeuchi, Toshihiko

AU - Hanaki, Hidekazu

AU - Yamada, Yasuo

AU - Narita, Nobuhiro

AU - Sawaki, Masayoshi

AU - Mikasa, Keiichi

AU - Miki, Fumio

AU - Soejima, Rinzo

AU - Okimoto, Niro

AU - Niki, Yoshihito

AU - Matsushima, Toshiharu

AU - Kimura, Makoto

AU - Yamakido, Michio

AU - Hasegawa, Kenji

AU - Oizumi, Kotaro

AU - Ichikawa, Yoichiro

AU - Tokunaga, Naoto

AU - Araki, Takeshi

AU - Fujino, Kazuma

AU - Hara, Kohei

AU - Kohno, Shigeru

AU - Kaku, Mitsuo

AU - Koga, Hironobu

AU - Ito, Naomi

AU - Matsumoto, Keizo

AU - Takasugi, Masakazu

AU - Watanabe, Hiroshi

AU - Nasu, Masaru

AU - Goto, Yoichiro

AU - Yamasaki, Tohru

AU - Goto, Jun

AU - Kitagawa, Kazuo

AU - Saito, Atsushi

AU - Irabu, Yuei

AU - Nakashima, Mitsuyoshi

AU - Deguchi, Koichi

PY - 1997

Y1 - 1997

N2 - A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200 mg q. d. (Group L) were compared with GPFX 300 mg q. d. (Group H) by the double-blind method, and each dose of GPFX was compared with open-label treatment with OFLX 200 mg t. i. d. (Group 0). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group 0) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2% (33/37), 97.6% (40/41), and 88.4% (38/43) in Groups L, H, and 0, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0% (15/20), 93.3% (14/15), and 85.7% (18/21) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and 0, the incidence of adverse reactions was 2.6% (1/39), 7.3% (3/41) and 9.1% (4/44), respectively, and the incidence of abnormal laboratory findings was 5.1% (2/39), 5.1% (2/39), and 4.9% (2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5% (32/37), 94.9% (37/39), and 85.4% (35/41) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300 mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.

AB - A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200 mg q. d. (Group L) were compared with GPFX 300 mg q. d. (Group H) by the double-blind method, and each dose of GPFX was compared with open-label treatment with OFLX 200 mg t. i. d. (Group 0). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group 0) were capable of being evaluated for efficacy. 1. Clinical efficacy: The clinical efficacy rate was 89.2% (33/37), 97.6% (40/41), and 88.4% (38/43) in Groups L, H, and 0, respectively. No statistically significant differences were observed among the 3 groups. 2. Bacteriological efficacy: The bacterial eradication rate was 75.0% (15/20), 93.3% (14/15), and 85.7% (18/21) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. 3. Safety assessments: In Groups L, H and 0, the incidence of adverse reactions was 2.6% (1/39), 7.3% (3/41) and 9.1% (4/44), respectively, and the incidence of abnormal laboratory findings was 5.1% (2/39), 5.1% (2/39), and 4.9% (2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups. 4. Usefulness: The usefulness rate was 86.5% (32/37), 94.9% (37/39), and 85.4% (35/41) in Groups L, H, and 0, respectively. No statistically significant differences were observed in the 3 groups. These findings demonstrated that 300 mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.

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M3 - Article

AN - SCOPUS:0030855090

SN - 1340-7007

VL - 45

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EP - 441

JO - Japanese Journal of Chemotherapy

JF - Japanese Journal of Chemotherapy

IS - 6

ER -

Comparative grepafloxacin dose-finding study in the treatment of chronic respiratory tract infection

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