M Okuda

Chiba University, Chiba-shi, Chiba-ken, Japan

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Publications (105)100.2 Total impact

  • [show abstract] [hide abstract]
    ABSTRACT: Dexamethasone cipecilate is a corticosteroid nasal spray whose local efficacy durability has been improved by introduction of a liposoluble functional group to its chemical structure. This study was conducted to evaluate the efficacy of once-daily treatment with this drug in patients with perennial allergic rhinitis by a challenge test with house dust antigen (Phase I clinical pharmacology study). This study was designed as a randomised placebo-controlled double-blind study in 28 patients with perennial allergic rhinitis. Either 200 μg dexamethasone cipecilate or placebo was administered once daily for 7 days, and the antigen challenge test conducted 23 h after the dose on each day. We evaluated the efficacy primarily through assessment of suppression of immediate nasal symptoms. When efficacy durability was evaluated by physicians based on a general assessment of the effects of suppression of nasal symptoms, the percentage of patients with efficacy lasting for 24 h differed significantly between the dexamethasone cipecilate group (69.2%, 9 out of 13) and the placebo group (15.4%, 2 out of 13) (p = 0.015). Dexamethasone cipecilate was shown to be a corticosteroid having sustainable local efficacy. The results suggest that once-daily administration of dexamethasone cipecilate is effective in patients with allergic rhinitis, and that its efficacy lasts for 24 h.
    Expert Opinion on Investigational Drugs 11/2010; 19(12):1475-86. · 4.74 Impact Factor
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    ABSTRACT: The efficacy of antihistamines in perennial allergic rhinitis in children has been evaluated in studies using active comparators, whereas placebo-controlled studies are very few. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship and superiority of olopatadine hydrochloride over placebo in children aged 7 to 16 years with perennial allergic rhinitis. Subjects received twice daily treatment for two weeks with either olopatadine 2.5 mg, 5 mg or placebo after a one-week observation period. Efficacy was assessed based on the diary card score the subject (or guardian) recorded. Of the 302 subjects randomized, two were excluded from analysis: one did not receive treatment; the other was not monitored for efficacy parameters. The remaining 300 subjects (97 in the placebo group, 103 in the olopatadine 2.5-mg group and 100 in the olopatadine 5-mg group) constituted the full analysis set (FAS) for the efficacy analysis. As a primary endpoint, the total three nasal symptom score (for sneezing, rhinorrhea and nasal congestion) at final assessment was compared with baseline or the score obtained in the observation period. The change from baseline was then tested using analysis of covariance (ANCOVA) with the baseline score as covariate. Williams' test was applied to the least squares means estimated from this ANCOVA model for each treatment group, resulting in showing the monotonicity Williams' test assumed. The total three nasal symptom score significantly improved in the 5-mg group compared with the placebo group (p = 0.019). In contrast, the 2.5-mg group did not differ statistically from the placebo group. Adverse events occurred in 33.7% (33/98 subjects) in the placebo group, 35.9% (37/103 subjects) in the 2.5-mg group and 35.0% (35/100 subjects) in the 5-mg group. There were no serious or severe adverse events. Olopatadine hydrochloride 5 mg twice daily is an effective and safe treatment for perennial allergic rhinitis in children.
    Current Medical Research and Opinion 07/2010; 26(7):1657-65. · 2.26 Impact Factor
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    ABSTRACT: In recent years, many countries have experienced an increase in the prevalence of allergic rhinitis. No effective approach is currently available to prevent the onset of symptoms in allergic individuals. Pranlukast, a leukotriene receptor antagonist with a good safety and efficacy record for the management of allergic inflammation, may be appropriate for early intervention in the management of pollinosis. To investigate the efficacy of pranlukast as an early intervention in the control of cedar pollinosis. In a double-blind comparative study, pranlukast (n = 102) or placebo (n = 91) was administered to cedar pollinosis patients immediately before the start of the dispersion season and continued for 4 weeks. Subsequently, pranlukast was administered to all patients for 2 weeks until the end of the cedar pollen dispersion season (mid-March). All patients were carefully monitored for severity of nasal symptoms, symptom scores, medication scores, symptom-medication scores, and quality of life (QOL). Compared with placebo, therapy with pranlukast before and during the dispersion of cedar pollen in these patients significantly improved nasal symptoms (paroxysmal sneezing, rhinorrhea, and nasal congestion), symptom scores, and symptom-medication scores. The drug also significantly reduced deterioration of QOL, and improved nasal symptoms and QOL throughout the dispersion period. Administering pranlukast immediately before the beginning of cedar pollen dispersion is effective in reducing symptoms of allergic rhinitis throughout the dispersion period.
    Journal of investigational allergology & clinical immunology: official organ of the International Association of Asthmology (INTERASMA) and Sociedad Latinoamericana de Alergia e Inmunología 02/2009; 19(3):195-203. · 1.89 Impact Factor
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    ABSTRACT: Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the treatment of allergic rhinitis. No previous clinical studies have compared the efficacy of FFNS with another intranasal steroid. The purpose of this study was to compare the efficacy and safety of FFNS, 110 microg/day, once daily with fluticasone propionate nasal spray (FPNS), 200 microg/day, twice daily in patients with Japanese cedar pollinosis to support the regulatory filing in Japan. In this multicenter, randomized, placebo-controlled, double-blind, parallel-group study, patients (>or=16 years old) were randomized to receive 2 weeks of treatment with FFNS (n = 151), FFNS placebo (n = 72), FPNS (n = 148), or FPNS placebo (n = 75). FFNS once daily was noninferior to FPNS twice daily in mean change from baseline in three total nasal symptom scores (3TNSS; sneezing, rhinorrhea, and nasal congestion; -1.23 +/- 0.140 and -1.06 +/- 0.142, respectively). Compared with placebo, FFNS was superior in reducing 3TNSS (p < 0.001). Both FFNS and FPNS showed similar mean changes from baseline in 4TNSS (3TNSS and nasal itching) and individual nasal symptom scores. The onset of action for FFNS was observed from the 1st day of treatment, whereas in the FPNS group it was observed on the 2nd day. There were similar improvements in rhinoscopy findings, activity of daily life interference, and patient-rated overall evaluation to therapy in the FFNS and FPNS groups. FFNS was well tolerated. Treatment with once-daily FFNS was effective and noninferior to twice-daily FPNS in reducing nasal symptoms. Faster onset of action for FFNS was observed.
    Allergy and Asthma Proceedings 01/2009; 30(1):84-94. · 2.19 Impact Factor
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    Minoru Gotoh, Kimihiro Okubo, Minoru Okuda
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    ABSTRACT: The incidence of Japanese cedar pollinosis is estimated to be about 13% of the Japanese population. In Japan it is generic to wear a facemask and eyeglasses to prevent pollen inhalation. We examined the usefulness of a facemask and eyeglasses in cooperation with volunteers. The number of pollen particles in the nasal cavity and on the conjunctiva was unchanged by wearing a facemask and eyeglasses. However, the pollen invasion rate was lower in subjects with a facemask and eyeglasses than in subjects without a facemask and eyeglasses. The decrease in pollen invasion rate in the nasal cavity due to wearing a facemask was statistically significant. This suggested that wearing a facemask has a protective effect on pollen invasion to the nose. The pollen invasion rate in the nasal cavity and on the conjunctiva was increased with increases in the wind speed. It may be difficult to avoid pollen even when wearing a facemask and eyeglasses when the wind speed is high. Further study is required to clarify the relationship between the amount of allergens and clinical symptoms.
    Rhinology 01/2006; 43(4):266-70. · 1.72 Impact Factor
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    ABSTRACT: Based on subjective symptom, it has been documented that so high as 21 to 62% of patients with Japanese cedar pollinosis has pollinosis symptom before the start of pollen season. Since this is not objectively evidenced, we aimed to clarify whether or not it is true. We quantified intranasal pollen by means of our nasal lavage method in patients with Japanese cedar pollinosis shortly after the onset of symptom during pre-, mid- and post-season from 1997 to 2005. Significant differences in intranasal pollen count were revealed among mid- and pre- and post-season. Intra-nasal pollens, so few as 1 or less, were found in 67.8% of patients having pre-seasonal symptom, while in 12.5% during the mid-season. The majority of patients had not sufficient number of intra-nasal pollen to induce pollinosis. However, the intranasal pollen counts in preseason were related well with total airborne pollen amount in next spring. Pollens other than Japanese cedar pollen were also detected in lavages. Many factors such as method of pollen survey, personal nasal hyper-reactivity and irritation by cold air, or with pollens other than Japanese cedar may cause the pre-seasonal pollinosis symptom. High frequencies of pre-seasonal onset in previous reports may be over-estimated due to inaccurate diagnosis of Japanese cedar pollinosis.
    Arerugī = [Allergy] 08/2005; 54(7):636-40.
  • Minoru Okuda, Kimihiro Ohkubo, Minoru Gotoh
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    ABSTRACT: Nasal symptoms such as sneezing, stuffy nose and runny nose occur in allergic and nonallergic rhinitis. Normal nose also sometimes has these symptoms. It is necessary to define what is the symptom of normal nose in order to make a proper diagnosis of rhinitis, grading of severity of nasal symptom in rhinitis and criteria of normalization after the treatment of rhinitis. 235 persons who had no perceptive nasal symptom and history of nasal disease at present and past, and cold at present, were sampled from the registered list of a health care organization, and examined their nasal symptom by mailing a self-administered questionnaire of nasal symptom. In addition, 54 patients, who visited 4 otolarngology clinics due to diseases other than rhinitis and were diagnosed as normal nose, were examined, using the same questionnaire. Response rate from persons mailed was 49.8%. Nasal symptom was infrequent in patients at clinic more than persons sampled from the list. Nasal symptom in 117 responders with normal nose had none or occasional and momentary stuffy nose. Sneezing and/or nose blow was less than 5 times a day, and itchy nose and postnasal drip were 30% and 25% respectively. These symptoms, if appeared, were less than 4 days per week. Grading "minus", normal, is zero in sneezing and runny nose and none in stuffy nose in the grading system of nasal symptom used commonly in Japan. These should be changed to none or occasional, momentary, easily tolerable in stuffy nose, less than once a day or grading "plus one" (1-5 times per day) occasionally in sneezing and nose blow. Normalization after treatment could be defined according to this change.
    Arerugī = [Allergy] 07/2005; 54(6):551-4.
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    ABSTRACT: To clarify natural airborne Japanese cedar pollen contamination of clothes (cotton made T shirt and cap) and face skin for preventive strategy against pollinosis. Ten non-pollinosis high school students, wearing T-shirt and cap, stayed after face washing in outdoor (school yard) and in-door (school room) for 2 hours alternatively. Wet clothes of each of three different qualities (cotton, cotton blended polyester and wool) were also left at ten points of the schoolyard. Contaminated pollens were collected using adhesive tape and counted under a microscope. Pollen contaminations were lesser in school room than school yard. Lesser contamination was revealed on the surface of cotton-polyester blended clothes without statistical difference when compared with cotton and wool made clothes. From this study, in going out wearing of cotton-polyester blended coat and cap, and after returning home, face washing and keeping coat and cap on a hanger at entry hall are recommended for pollen prevention.
    Arerugī = [Allergy] 07/2005; 54(6):555-8.
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    ABSTRACT: Pollinosis is common worldwide, and has been frequently studied. However, the intranasal dynamics of pollen grains have not yet been documented. The purpose of this study is to elucidate for the first time the dynamics of Japanese cedar pollen (JCP) in the human nose at consecutive steps from inhalation to allergic reaction together with release of Cry j 1 (a major allergenic component of JCP) in the nose. A personal sampler collected airborne pollens at head height outdoor on the street, while intranasal pollens after natural or experimental inhalation were collected by irrigation with 200ml saline. Cry j 1 in the supernatant after in vitro incubation with phosphate buffered saline or lavage was determined by enzyme-linked immunoassay. Head-height pollen was 183.0 +/- 43.1/300L/h, with 99% of the inhaled pollens deposited on the nasal surface. Eighty eight% of the inhaled pollen was transported to the out-side of the nose by ciliary function within 3 hours. During this process, considerable amounts of Cry j 1 were released in the nose reaching its plateau within 30 min. When the number of pollen deposited exceeded more than approximately 65 particles, symptoms may occur, leading presumably up to a 74% reduction of the intra-nasal pollen. The majority of inhaled airborne pollens was deposited on the nasal mucosal surface and moved out from the nose by mucociliary transportation. During this process, when allergenic substances are released up to a critical concentration, allergic reactions occur leading to expelling of pollen from the nose followed by subsiding of the symptoms.
    Rhinology 04/2005; 43(1):29-33. · 1.72 Impact Factor
  • Minoru Okuda, Kimihiro Ohkubo, Minoru Gotoh
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    ABSTRACT: Patient satisfaction is recommended as a parameter to evaluate medical care from the aspect of patient. Currently, we developed a new patient satisfaction questionnaire in allergic rhinitis by means of internationally standardized psychometric validation and reliability studies. Using this questionnaire, we evaluated patient satisfaction with Japanese cedar pollinosis in 2004, who visited our own clinic (JAAC) or patients, who were sampled from the list of a health research company (JSR), in addition of literature data. As a result, there were marked differences between ours and others. The purpose of this study is to elucidate whether or not our questionnaire has a good and reliable clinical validity, and, if yes, why there were marked differences in various studies. The satisfaction (very good plus good) was 94.4% in the JAAC group and 41.2% in the JSR group respectively. We compared the mean scores of each item in questionnaire in both groups, and found higher scores in the majority of items in the former group than the latter group in accordance with difference in satisfaction. This suggested a good clinical validity in questionnaire. In nasal treatment modality, the JAAC group was. characterized by continuous use of combined topical steroid with per oral anti-allergic compound and immunotherapy during whole pollen season, when compared with the JSR group. A persistent contact with patients in immunotherapy plays an important role in establishing good doctor-patient relation and treatment outcome, resulting in increased patient satisfaction.
    Arerugī = [Allergy] 02/2005; 54(1):12-7.
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    ABSTRACT: Although currently in its infancy, quality of life (QOL) research in Japan is rapidly expanding and is expected to become a standard outcome measure in clinical trials. In Japan, QOL has not previously been assessed in patients with allergic rhinitis (AR); we report the first clinical study applying the recently validated Japanese translations of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Questionnaire to assess the effects of the oral antihistamine, fexofenadine, on QOL and work productivity due to cedar pollinosis. A randomized, double-blind, placebo-controlled, single-site study was conducted during the peak cedar pollinosis season in Japan. After a 7-day run-in period, subjects were randomized to receive fexofenadine HCl 60 mg twice daily (bid) or placebo for 2 weeks. Overall, 206 Japanese subjects with AR were included in the intention-to- treat population (fexofenadine, n = 104, and placebo, n = 102). Fexofenadine statistically significantly improved overall QOL compared with placebo (p = 0.005) and improvements were reported in the RQLQ domains: activities (p = 0.047), practical problems (p = 0.003), nasal symptoms (p = 0.003) and eye symptoms (p </= 0.001). Clinically significant improvements in practical problems, eye symptoms and activity limitations, exceeding the 0.05 level, were observed with fexofenadine. These improvements in QOL were associated with significant symptom relief (p < 0.001 vs. placebo). Improvements in impairment at work were also reported with fexofenadine. In Japan, this is the first clinical study to show that fexofenadine HCl (60 mg b.i.d.) improves overall QOL and work productivity in patients with seasonal AR using validated Japanese instruments.
    International Archives of Allergy and Immunology 02/2005; 136(2):148-54. · 2.25 Impact Factor
  • Minoru Okuda, Kimihiro Ohkubo, Minoru Goto
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    ABSTRACT: Recent suggestions emphasize the importance of assessing medical care outcomes from the point of view of both professional opinion and patient's subject like patient satisfaction as well as quality of life. Self-administered questionnaires are often used as an instrument for this purpose. When compared with quality of life, there is less useful questionnaire for patient satisfaction. Accordingly, we here aimed to develop the questionnaire, which is disease-specific, comprehensive, simple, clinically available and satisfied psychometric validation study. The items were collected from patients and satisfaction-related literature's review, and the total 20 were selected finally from them after excluding inadequate or overlapped items. Then, we conducted validation study in 214 subjects sampled randomly from 603 patients with Japanese cedar pollinosis who had visited clinics in 2003 by mailing self-administered questionnaire in spring, 2004. The response rate was 65.3%. In factor analysis, items were divided into four domains such as doctor-patient relationship, treatment outcome, geniality in hospital and convenience of medical service. The former two domains were the most correlated well with patient satisfaction. The quality of this questionnaire such as responsiveness, reliability, construct validity, convergent/discriminate validity, and clinical validity satisfied international standard. Thus, it was verified that our newly developed questionnaire is a useful and scientific tool for examination of patient satisfaction with medical care in allergic rhinitis.
    Arerugī = [Allergy] 01/2005; 53(12):1195-202.
  • Minoru Okuda, Kimihiro Ohkubo, Minoru Goto
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    ABSTRACT: It is approved that ENT doctors are specialist for pollinosis. Is it true from the point of view of patients' medical care-seeking behavior? 214 patients with Japanese cedar pollinosis who had visited medical doctors in 2003 pollen-season were randomly sampled from 603 pollinosis patients registered at a disease survey company and we mailed self-evaluation questionnaire on patients' medical care-seeking behavior on the end of pollen season in 2004. Response rate was 65.3%. Patients visited clinics in approximately 90% more than hospitals. They selected ENT in 43.9% and general physicians in 31.1%. Their selections were based on others than their specialty such as easy access and previous experience of visit, because pollinosis is not serious disease like cancer. ENT doctors treated the patients by combination of two kinds of tablet or topical steroid with tablet, while general physicians did with single kind of tablet. The patient satisfaction, and its related questions including preference, wish to revisit in next year and recommendation to their friend were not different in treatment between ENT and general physician. Doctors' attitude, and communication with patients were the most important factor for patient satisfaction as well as treatment out-come. In conclusion, patients prefer agreeable and convenient treatment. If ENT doctors still want to be specialist for pollinosis, they should take care patients well and develop their own specific treatment methodology to cure this disease.
    Arerugī = [Allergy] 12/2004; 53(11):1144-51.
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    ABSTRACT: Background: The aim of the present survey was to investigate the changes associated with fexofenadine administration in the quality of life (QOL) of Japanese cedar pollinosis patients.Methods: After obtaining informed consent, volunteers suffering from Japanese cedar pollinosis were divided into two groups: (i) the fexofenadine group (2 × 60 mg/day); and (ii) the placebo group. Changes in QOL were examined after administration for 14 days (randomized, double-blind comparison study). The study period was from 27 February to 13 March 2003. Subjects were recruited from the Tokyo metropolitan area; 104 were randomized to the fexofenadine group and 103 were randomized to the placebo group. The QOL was evaluated using the Japanese Allergic Rhinitis Standard QOL Questionnaire (JRQLQ no. 1). The JRQLQ is structured to evaluate six domains of usual daily activities, outdoor activities, social functioning, sleep problems, general physical problems and emotional function, as well as the overall QOL.Results: On the 14th day after the start of fexofenadine or placebo administration, the QOL was improved in all domains of the JRQLQ in the fexofenadine group, whereas it had worsened in all domains, except outdoor activities, in the placebo group. The overall evaluation of QOL was significantly more favorable in the fexofenadine group on the 14th day after the start of administration.Conclusions: The present study showed that fexofenadine administration suppressed the deterioration of overall QOL and alleviated the interference with daily life in patients suffering from Japanese cedar pollinosis.
    Allergology International 08/2004; 53(3):245 - 254.
  • K. Okubo, M. Gotoh, M. Okuda
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    ABSTRACT: The prevalence of childhood allergic rhinitis is increasing steadily in Japan. Affected children are sensitized mainly by house dust mites; however, the prevalence of Japanese cedar pollinosis (JCP) in children is also on the rise. To ascertain the prevalence and current status of JCP in Japanese children, a retrospective analysis of a nationwide cross-sectional random sampling study was conducted. The survey, conducted shortly after the peak pollen season, was performed by self-evaluation questionnaire in 2001. Data from children aged under 15 years were collected and analysed. In these subjects, the response rate was 75.1%. The prevalence of JCP was 10.2% in children. Rhinorrhoea was the severest symptom reported; 19.5% had severe or moderate interference with daily activities and consulted physicians. Few children used prescribed drugs and some took measures to avoid contact with allergens.
    Clinical & Experimental Allergy Reviews. 07/2004; 4(1):31 - 34.
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    ABSTRACT: Japanese cedar pollinosis is a major public health problem in Japan because of its severe symptom and high prevalence. However, patient satisfaction by treatment is poor according to current reports. As the treatments, pre-seasonal medication and single peroral anti-allergic drug on demand are frequently used in Japan. Against conventional methods, we treated 301 patients with Japanese cedar pollinosis by persistent use of combined drugs (topical steroid, peroral anti-allergic drug and eye drop) without pre-seasonal medication in 2003. Immunotherapy was also used in 90 patients treated. As a result, 97% of patients was satisfied in this treatment and immunotherapy contributed to reduction in the amount of drug and high treatment outcome.
    Arerugī = [Allergy] 07/2004; 53(6):596-600.
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    Minoru Gotoh, Kimihiro Okubo, Minoru Okuda
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    ABSTRACT: Background:  In allergic rhinitis, antigen−antibody reactions occur in the nasal mucosa through antigen exposure. A strong reaction occurs following exposure to a large amount of antigen, whereas no reaction occurs in the absence of antigens. In seasonal allergic rhinitis, nasal hypersensitivity increases during the pollen-dispersing season, which is known as the ‘priming effect’. The purpose of the present study was to clarify whether repeated nasal challenges bring about increased nasal hypersensitivity in patients with perennial allergic rhinitis.Methods:  Fourteen patients with perennial allergic rhinitis to house dust mites were enrolled in the present study. Repeated challenge tests were performed once daily for 8 consecutive days with a fixed amount of antigen.Results:  Sneezing and nasal secretion were slightly enhanced by repeated challenges only on the 2nd and 3rd days, whereas nasal resistance remained unchanged. Increased sneezing and nasal secretion was marked in a group of subjects who were not sneezing at the first challenge, whereas changes in nasal reaction following repeated challenge were less obvious in subjects who were sneezing at the first challenge.Conclusions:  In contrast with pollinosis, nasal provocation reactions were not clearly enhanced by repeated provocation. To further understand nasal reactions induced by antigen challenge, studies should be performed under specified conditions (i.e. in an experimental room) with a prescribed quantity of antigens administered, as well as within a study environment.
    Allergology International 11/2003; 52(4):207 - 212.
  • Arerugī = [Allergy] 08/2003; 52 Suppl 1:70-86.
  • Arerugī = [Allergy] 08/2003; 52 Suppl 1:21-56.
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    ABSTRACT: A study was conducted in 165 subjects with Japanese cedar pollinosis (JC) to evaluate the switching to the new standardized extract (SE) for patients who are going on specific immunotherapy (SP-IT) with conventional non-standardized extracts, products of Trii Co. or Hollister-Stier Co. Eight of 137 subjects exhibited adverse systemic reactions such as general skin eruption and despnea when JC allergen extract of Hollister-Stier Co. was switched to JC-SE. There were 6 cases where concentration of the extract had to be decreased due to extraordinary late reactions, while none of 28 subjects exhibited adverse side effect, when conventional allergen extract by Torii Pharmaceutical Co. was switched to JC-SE. Careful switching to high concentration of SE is required, because eight cases with adverse side effect were shown in switching to 200 JAU/ml and 2000 JAU/ml. 20 subjects started with SP-IT by JC-SE after spread of JC in the year of 2000 exhibited no adverse side effects in our protocol.
    Arerugī = [Allergy] 07/2001; 50(6):520-7.

Publication Stats

595 Citations
100.20 Total Impact Points

Institutions

  • 2009
    • Chiba University
      • Department of Otorhinolaryngology, Head and Neck Surgery
      Chiba-shi, Chiba-ken, Japan
  • 1980–2009
    • Nippon Medical School
      • • Department of Otolaryngology
      • • Nippon Medical School Hospital
      Tokyo, Tokyo-to, Japan
  • 2004
    • Clinical Research Hospital, Tokyo
      Edo, Tōkyō, Japan
  • 1997
    • Juntendo University
      • Department of Immunology
      Tokyo, Tokyo-to, Japan
  • 1988
    • National Taiwan University Hospital
      T’ai-pei, Taipei, Taiwan
  • 1978
    • Wakayama Medical University
      • Department of Otolaryngology
      Wakayama, Wakayama, Japan