1. 1) Gross NJ; Co E; Skorodin MS. Cholinergic bronchomotor tone in COPD: estimates of its amount in comparison with that in normal subjects. Chest 19
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1 1. 1 COPD COPD COPD COPD COPD COPD Quality of life QOL 2 COPD 1) COPD 2 3 COPD COPD 18mcg 1 1 M 1 M 2 M 3 M 2 M 1 M 3 M 3 M
2 1. 1) Gross NJ; Co E; Skorodin MS. Cholinergic bronchomotor tone in COPD: estimates of its amount in comparison with that in normal subjects. Chest 1989 ;96 (5) : ) Harris LH. Effects of isoproterenol plus phenylephrine by pressurized aerosol on blood gases, ventilation, and perfusion in chronic obstructive lung disease. Br. Med. J ;5 : ) Gross NJ; Co E; Skorodin MS. Role of the parasympathetic system in airway obstruction due to emphysema. N Engl J Med :311(7) : COPD COPD
3 1. ATS AUC BDI COPD ERS FEV1.0 %FEV1.0 FVC FEV1.0/FVC GOLD ITT mcg PEFR QOL SGRQ TDI WHO American Thoracic Society Area Under the Curve Baseline Dyspnea Index Chronic Obstructive Pulmonary Disease European Respiratory Society 1 Forced Expiratory Volume in 1 Second FEV1.0 Forced Vital Capacity 1 Global Initiative for Chronic Obstructive Lung Disease Intent-to-Treat microgram Peak Expiratory Flow Rate Quality of Life St. George s Respiratory Questionnaire Transitional Dyspnea Index World Health Organization FEV FEV FEV1.0 WHO ART Adverse Reaction WHO Terminology WHO WHO Preferred Term 3
4 , ( 1 crossover crossover mcg 68* mcg FEV1.0 FEV * mcg FEV mcg FEV mcg FEV * A B mcg FEV * mcg mcg 25 FEV (TDI) 26 FEV
5 mcg 35.2mcg COPD FEV mcg 17.6mcg COPD mcg FEV mcg 1 1 COPD A B 17 QOL COPD FEV FEV1.0 FEV1.0 FEV L L FEV Mahler Baseline Dyspnea Index BDI Transitional Dyspnea Index TDI TDI
6 2. QOL St. George s Respiratory Questionnaire SGRQ COPD COPD COPD COPD COPD COPD 12 16% mcg 1 1 COPD ICH E5 COPD
7 COPD FEV1.0 crossover FEV1.0 36mcg 18mcg COPD /128 14/ A/126B 16/17 FEV1.0 18mcg 36mcg mcg FEV1.0 18mcg 36mcg /128 14/ A/126B 16/17 18mcg 1 COPD FEV1.0 SGRQ 17.3% 5.9% COPD 10.9% 17.6% FEV1.0 SGRQ 7
8 (1) (2) FEV /128 14/ A/126B 16/17 FEV1.0 4 (3) /128 14/ A/126B 16/17 FEV
9 ICH E ICH E5 D D * COPD mcg COPD mcg mcg mcg FEV mcg % mcg FEV1.0 18mcg 36mcg 18 36mcg 1.5% 27.3% 0% 6.1% 0% 4.5% 36mcg
10 D * ( ) 74% Ba 338 BR CYP3A4 2D6 20% 3% % ,000 P-450 in vitro CYP AUC 20% COPD COPD 12 13
11 ICH A COPD COPD COPD 1995 ATS 1 ERS Global Initiative for Chronic Obstructive Lung Disease GOLD ATS ERS COPD COPD COPD COPD COPD COPD X CT 11
12 COPD COPD COPD COPD QOL COPD ATS ERS 2 COPD COPD COPD %FEV *1 *3 *2 *4 56.1% 60.4% 76.6% 68.9% 23.6% 15.9% 61.7% 67.7% % 38.3% 21.4% 28.0% 42.0% 80.4% 14.9% 18.6% * * A B 17* *
13 %FEV *1 *3 *2 *4 N N N N % 31.3% % % % 60 30% 50% 45.5% % % % 72 50% 70% 22.6% % % % 26 70% 0.7% 6 0.9% 5 0.5% 1 1.2% % 43.1% % * * A B 17* * FEV
14 FEV1.0 %FEV1.0 GOLD ATS Stage ATS ERS %FEV1.0 50% ATS 35% Stage GOLD 2003 %FEV1.0 80% 50% 80% 30% 50% 30% Stage I Stage II Stage III (2003 ) COPD 1996 COPD % COPD COPD COPD % COPD COPD 11 ATS 1995 COPD 4 6% 1 3% 14
15 ATS ERS COPD GOLD GOLD COPD COPD ATS ERS COPD ERS ATS GOLD FEV COPD FEV1.0 FEV1.0 COPD 12-13) COPD FEV COPD 15
16 3. 1) ATS Statement. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1995; 152:S77-S120. 2) ERS-Consensus Statement. Optimal assessment and management of chronic obstructive pulmonary disease (COPD). Eur Respir J 1995; 8: ) British Thoracic Society. BTS Guidelines for the management of chronic obstructive pulmonary disease. Thorax 1997; 52:S1-S28. 4) COPD COPD ) Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: NHLBI/WHO Workshop report ) Burge PS, Calverley PMA, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. Br Med J 2000; 320 (7245): ) Pauwels RA, Lofdahl CG, Laitinen LA, Schouten JP, Postma DS, Pride NB, Ohlsson SV. Long-term treatment with inhaled budesonide in persons with mild chronic obstructive pulmonary disease who continue smoking. N Engl J Med 1999; 340 (25): ) Vestbo J, Sorensen T, Lange P, Brix A, Torre P, Viskum K. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 1999; 353 (9167): ) The Lung Health Study research Group. Effect of inhalated triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med 2000, 343 (26): ).. COPD. 2001, 196 (9): ) Fukuchi. Y, Nishimura M, Ichinose. M et al. Prevalence of chronic obstructive pulmonary disease in Japan : Results from the Nippon COPD epidemiology (NICE) study. Poster session 181 p1849, ERS 24, September 2001, Berlin, Germany. 12) Traver GA, Cline MG, Burrows B. Predictors of mortality in chronic obstructive pulmonary disease. Am Rev Respir Dis 1979, 119: ) Anthonisen NR, Wright EC, Hodgkin JE, et al. Prognosis in chronic obstructive pulmonary disease. Am Rev Repspir Dis 1986, 133:
17 * < No.> ( No.) 24 ( ) mcg: 6 : mcg: 6 :4 PD 0.8, 4, 8, 20, 40, 80, 160mcg, 1 ( ) -1 < > (U ) ( ) FO2-1 1 < > 35.2, 70.4, 140.8, ( ) (U ) 281.6mcg, 12 (3 way 70.4mcg:11 ) 16 crossover ) 140.8mcg:12 :12 15 ( ) mcg: mcg:5 16mcg:6 32mcg:5 64mcg:6 :4 ( mcg: 6 :4 FO2 70.4, 140.8mcg, 1 1 FO2 8.8, 17.6, 35.2mcg 1 1 8, 16, 32, 64mcg, 2.4, 4.8, 9.6, 14.4mcg, ( 4.8, 9.6mcg ) * : PD : piezoelectric HH : -2 7 < > ( ) (U ) < > ( ) (U ) -4 1 < > ( ) (U ) 1 ( ) -5 < > (U ) 17
18 * < No.> ( No.) mcg: ( ) 6 :12 36 ( ) , 0.04, 0.08, 0.16, 0.28, 0.4mcg, :64mcg -6 1 < > ( ) (U ) -7 HH 1 < > 108mcg ( ) (U ) 14.4mcg COPD COPD 29 HH 18mcg < > ( ) (U ) mcg 1 2 ( ) -9 < > (U ) mcg < ( ) (U ) 6 ( mcg: ) 6 COPD PD 1 ( ) 8, 16, 32, 64, 128mcg -2 < > (U ) ( ) COPD 8.8mcg:34 (5 way cross 17.6mcg:33 over ) 35.2mcg: mcg:34 :35 FO2 8.8, 17.6, 35.2, 70.4mcg, < > ( ) (U ) COPD (4 way cross over ) 27 9mcg:26 18mcg:27 36mcg:26 :26 HH -12 9, 18, 36mcg, 1 < > ( ) (U ) * : PD : piezoelectric HH : 18
19 < > * COPD mcg: mcg:33 ( ) 17.6mcg: mcg:34 :35 FO2 4.4, 8.8, 17.6, 35.2mcg, 1 1 < No.> ( No.) 4 9 ( ) -13 < > (U ) 470 :279 1 :191 ( ) 451 COPD :271 : < > (U ) HH 18mcg, < > (U ) < A> :191 (U ) :97 HH 18mcg ( ) MDI mcg < B> :165 (U ) :82 COPD HH , 36mcg mcg : ( ) 36mcg : 66 : 68 MDI 200mcg 1 3 COPD HH 18mcg ( : 110 : 51 COPD MDI 200mcg 1 3 * : PD : piezoelectric HH : < > 19
20 * < No.> ( No.) 6 ( ) COPD 623 :209 :213 : :193 :192 : ( < > (U ) HH 18mcg ) MDI 50mcg ( < > 6 (U ) 15 ) HH 18mcg ( ) :20 :11 MDI 40mcg :43 ( ) :38 :40 HH < > 18mcg, ( (U ) 1 1 ) 38 HH < > ( ) :19 18mcg, (U ) : COPD -22 < > (U ) A 1 95 :33 ( ) :32 :30 HH < > 18mcg, ( (U ) 1 1 ) 26 :26 HH < > (U ) * : PD : piezoelectric HH : 20
21 Piezoelectric mcg FO mcg 160mcg mcg 140.8mcg 1 1 FO mcg 1 1 FO mcg 17.6mcg 20% 35.2mcg 60% 70.4mcg 64% 140.8mcg 100% 35.2mcg mcg mcg mcg mcg mcg 64mcg 108mcg COPD 8 18mcg 14 21
22 mcg 5 COPD 24 64mcg mcg crossover COPD FEV mcg 17.6mcg mcg crossover COPD FEV1.0 36mcg 18mcg 24 22
23 mcg mcg COPD 4 1 FEV1.0 FEV1.0 1 FEV1.0 1 FEV mcg % 18mcg COPD 18mcg FEV FEV1.0 1 FEV L 12% FEV L 1 FEV1.0 TDI % 27 34% 1 QOL SGRQ % 30 34% 23
24 4. COPD COPD COPD COPD COPD COPD COPD COPD A B FEV1.0 FEV FEV L 12% FEV L TDI % 18 35% 6 QOL SGRQ % 35 48% 9 COPD COPD COPD COPD 24
25 4. COPD COPD COPD COPD % 91.1% 89.3% 90.5% 1% 16.0% 2.7% 12.1% 6.1% COPD 18 36mcg mcg FEV FEV1.0 2 FEV mcg A B 17 18mcg 25
26 COPD 18mcg 1 COPD 10% COPD 17.3% 5.9% COPD 10.9% 17.6% 49.1% 45.1% 5.5% 6/ % 4/ % 9.8% A B % mg/dL % 8 10% 4 5% FEV1.0 1 SGRQ 1 4 COPD 26
27 FEV1.0 FEV FEV L 10% FEV L TDI TDI FEV % 40 41% 28 30% 6 QOL SGRQ % 43% 39% COPD COPD COPD COPD COPD COPD COPD 2 COPD 1 1% 27
28 4. 8.2% 1.7% 2.3% mcg mcg TBC Tc m 18mcg FEV1.0 penetration index PI tracheobronchial retention :TBR TBC TBC mcg REM SaO % %FEV % COPD L/min 20 L/min 28
29 Piezo-electric PD Kg 77.5Kg , 4, 8, 20, 40, 80, 160mcg: 6 :6 0.8, 4, 8, 20, 40, 80, 160mcg Piezoelectric Piezoelectric * 24 * 8 mcg RAW 20 30% mcg mcg mcg 29
30 mcg/kg/ mcg/ 1/ mcg mcg WHO Preferred Term N (%) N (%) N (%) N (%) (17) 1 (17) 3 (50) 1 (17) 2 (33) 1 (17) (50) 1 (17) mcg WHO Preferred Term N (%) N (%) N (%) N (%) (17) 4 (67) 5 (83) (17) 0 1 (17) 4 (67) 4 (67) 0 30
31 FO FO Kg 78.5Kg , 70.4, 140.8, 281.6mcg: 6 :4 35.2, 70.4, 140.8, 281.6mcg FO2 FO * 24 * mcg mcg 24 RAW 15 30% mcg mcg mcg mcg (mcg) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) (17) 0 4 (67) 5 (83) 0 1 (17) 0 1 (17) (50) 5 (83) 0 31
32 FO mcg for drug development, Dekker, NY, FO2 3 way crossover Kg 74Kg mcg: mcg:12 : mcg mcg 11 Peace,K.E.: Biopharmaceutical statistics 70.4, 140.8mcg 1 1 FO2 1 1 FO mcg mcg RAW 30 35% 72 15% mcg mcg mcg mcg 10 32
33 mcg (mcg) WHO Preferred Term N (%) N (%) N (%) (91) 12 (100) 5 (42) (8) 7 (64) 12 (100) (8) 0 ( ) (8) 2 (18) 2 (17) 2 (17) 0 2 (17) 0 7 (64) 10 (83) (8) 0 3 (25) 0 33
34 FO mcg for drug development, Dekker, NY, FO Kg 73Kg mcg 5 Peace,K.E.: Biopharmaceutical statistics 8.8, 17.6, 35.2mcg 1 1 FO mcg 1 13 RAW mcg mcg mcg mcg 34
35 (mcg) WHO Preferred Term N (%) N (%) N (%) (60) 3 (60) 5 (100) (20) 2 (40) 1 (20) (20) 0 1 (20) 3 (60) (40) 3 (60) 1 (20) 2 (40) 35
36 Kg 79Kg mcg 5 16mcg 6 32mcg 5 64mcg 6 4 No mcg2 2 4 No mcg2 2 4 No mcg Broom C. Design of first-administration studies in healthy man. Early Phase Drug Evaluation in Man.O'Grady J, Linet OI (Eds.), Macmillan Press: London, 1990, , 16, 32, 64mcg 30 * * * 24 * mcg (mcg) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) (25) (25) 36
37 * Kg 81.4Kg mcg mcg A 6 1 B 2 4.8mcg C 6 2 D 2 9.6mcg A 6 2 B mcg C 6 1 D mcg 24 2 B 1 No mcg 4 6 Broom C. Design of first-administration studies in healthy man. Early Phase Drug Evaluation in Man.O'Grady J, Linet OI (Eds.), Macmillan Press: London, 1990, mcg mcg mcg mcg mcg * 25* 45 * * * mcg 1 9.6mcg mcg mcg 37
38 (mcg) (1) (2) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) N (%) (17) 2 (33) 0 1 (25) (17) 2 (33) 0 1 (25) (17) (17) ( ) (25) 0 ( ) (17) mcg mcg 38
39 Kg 80Kg mcg mcg / 50mcL 0.40mcg BINEB 1 18mcg BINEB 1% 0.18mcg 18mcg mcg 0.4mcg mcg BINEB (mcg) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) N (%) N (%) (33) 1 (17) 3 (50) 3 (50) 0 2 (33) 4 (33) 1) 2 (33) 1 (17) 3 (50) 2 (33) 0 1 (17) 3 (25) 2) (17) (17) (8) mmhg
40 bioavailability Kg 83Kg mcg 64mcg 108mcg 12 bioavailability mcg 36mcg 3 64mcg 14.4mcg bioavailability CmaxAUC mcg 64mcg 108mcg (mcg) WHO Preferred Term N (%) N (%) N (%) (42) 5 (42) 2 (17) ( ) 0 1 (8) (8) 0 1 (8) 1 (8) 1 (8) 1 (8) (17) ( ) 3 (25) 3 (25) 1 (8) (8) 40
41 COPD COPD FEV1.0 FVC FEV1.0/FVC COPD COPD Kg 67.9Kg * ** 43 98Kg 66.0Kg * 43 98Kg 67.7Kg ** * ** mcg AUC 0-4h Ae 0-4h CL R t 1/ C 5min T max % 95% C 5min pg/ml AUC 0-4h pg h/ml Ae 0-4h % of dose CL R ml/min t 1/2 Days COPD 5 1 COPD 41
42 5. 1 COPD FEV % 7.7% 7.3% 10.0% 4.5% 9.2% 10.4% 9.5% mcg WHO Preferred Term N (%) N (%) (17) 10 (59) 0 1 (6) 0 1 (6) 1 (8) (6) 1 (8) (6) 1 (8) (6) 0 1 (6) 1 (8) 0 1 (8) 5 (29) 0 1 (6) 0 1 (6) 0 1 (6) 0 2 (12) 42
43 CL CR * >80 ml/min ml/min ml/min <30 ml/min CL CR * Kg 83.74Kg 82.36Kg 68.50Kg *: mcg AUC 0-4h Ae 0- CL R t 1/2 C max C max (pg/ml) AUC 0-4h (pg h/ml) Ae 0- (% of dose) t 1/2 (days) CL R (ml/min) /6 33%
44 5. WHO Preferred Term N (%) N (%) N (%) N (%) N (%) (33) (8) 2 (33) (8) 44
45 crossover Kg 55Kg Kg 72Kg 6 12 (Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 1992 ;30 (Suppl 1) :S51 -S58.) 14.4mcg 400mg 300mg mcg 1 400mg mg C max AUC 0-4h Ae 0-4h CL R AUC 0-8h Ae 0-96h 45
46 5. N N AUC 0-4h Pg.h / ml C max Pg / ml Ae 0-4h % of dose CL R ML / min N N AUC 0-4h Pg.h / ml C max Pg / ml Ae 0-4h % of dose CL R ML / min C max AUC 0-4h C max No.11 No No.12 No WHO Preferred Term N (%) N (%) N (%) N (%) N (%) (17) 2 (15) 4 (21) 3 (50) 4 (31) (5) 0 1 (8) (5) 0 2 (15) (11) (8) (8) (8) 1 (17) (17) (17) 1 (8) (8) (17) (8) (8) 46
47 COPD 8 128mcg COPD 8 128mcg 5 COPD 1) FEV1.0 %FEV1.065% 1 FEV1.0/FVC 70% 2) MDI 20mcg 2 30 FEV1.0 15% 3) ) 10 pack-year (pack-year 1 20 ) 5) / L mcg Piezoelectric 2 1) FEV1.0 T max AUC 2) FVC MEF25 MEF50 MEF75 RAW sgaw TGV 3)
48 wash out Visit Number mcg 16mcg 32mcg 64mcg 128mcg X X X X X X X X X X X X X X X X X 1) 2) 24 X X X X X X X X X X X X X X X X X mcg visit Visit 2 5 FEV1.0 visit 1 15% mcg 8mcg 128mcg 48
49 COPD FEV L%FEV % FEV % N S.D. 4 2 (pack-years) 10 6 ( ) FEV1.0 (L) %FEV1.0 (%) FEV1.0 (%) FEV FEV1.0 15% FEV mcg 21% 16mcg 30% 32mcg 32% 64mcg 47% 128mcg 43% 64mcg morning dip 19 FEV FEV
50 mcg (mcg) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) (16.7) 0 ( ) (16.7) (16.7) mcg COPD 64mcg FEV1.0 FEV1.0 15% FEV1.0 morning dip
51 COPD mcg crossover COPD mcg 5 way crossover COPD 1 FEV1.0 %FEV1.0 65% 1 FEV1.0/FVC FEV1.0% 70% 2 MDI 20mcg 2 30 FEV1.0 15% 3 10 pack-year (pack-year 1 20 ) / L mcg mcg mcg mcg FEV mL FEV mL 5% 90% mcg FO2 FO FEV1.0 2 FEV1.0 T max AUC FVC FEF 25-75%
52 wash out ACE MAO 5 2 FEV1.0 LOCF FEV1.0 AUC 1) mcg Visit Number X X X X X X X X X 1) 2) 32 X X X X X X X X X X X X X X X X X visit 30 2 Visit 2 5 FEV1.0 visit 1 15% 52
53 COPD FEV FEV L%FEV % 30 FEV % ( ) 35 ( ) N S.D (pack-years) ( ) (cm) (kg) FEV1.0 (L) %FEV1.0 (%) FEV1.0 / FVC (%) FEV1.0 (%)
54 mcg FEV FEV morning dip 17.6mcg FEV
55 FEV mcg 35.2mcg LSMean L SE L % DunnettDunnett 8.8mcg p= FEV mcg p= mcg p= mcg p= LSMean FEV FEV AUC 0-24hr AUC 0-32hr 35.2mcg FEV1.0 AUC0-24hr AUC0-32hr (mcg) AUC 0-24hr (L) AUC 0-32hr (L)
56 % 42.9% (mcg) WHO Preferred Term N (%) N (%) N (%) N (%) N (%) * *
57 N N N (2.9) 35 3(8.6) 35 1(2.9) (2.9) GTP AST (GOT) ALT (GPT) (2.9) 34 1(2.9) 35 1(2.9) 35 1(2.9) (2.9) (2.9) 35 1(2.9) 35 3(8.6) PH way crossover FEV mcg FEV mcg morning dip 32 57
/ / A/ B 16/17 COPD 18mcg COPD COPD COPD 1
11 1 -------------------- 19 205.117/205.128 14/15 205.126A/205.126B 16/17 COPD 18mcg COPD 11.1 11.1.1 COPD 100 19 205.227 COPD 1 FEV1.0 %FEV1.0 70% 1 FEV1.0 / FVC 70% 2 1 200 3 40 COPD 1 10mg ACE 1 1
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