TRIple in Asthma 고강도 대 Ics/Laba hs 및 tiotRopium(TRIGGER) (TRIGGER)
A 52주, 무작위배정, 이중 맹검, 다국적, 다기관, 능동 제어, 3군 병렬 그룹 시험 비교 CHF 5993 200/6/12.5µg pMDI(초미세 베클로메타손 디프로피오네이트 플러스 포르모테롤 푸마르산염 플러스 글리코피로늄 015 CROM 2의 고정 조합) 015 /6 µg pMDI(초미세 베클로메타손 디프로피오네이트 플러스 포르모테롤 푸마레이트의 고정 조합) 단독 또는 공개 라벨 TIOTROPIUM 2.5 µg Respimat® 위에 장기간 작용하는 ß2-효능제와 함께 고용량 흡입 코르티코스테로이드로 조절되지 않는 천식 환자에게
연구 개요
상태
정황
상세 설명
This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.
The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.
Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.
Primary objective of the study were:
- To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
- To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.
The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.
CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.
BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Berlin, 독일
- Chiesi Clinical Trial Site 276709
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Berlin, 독일
- Chiesi Clinical Trial Site 276712
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Bonn, 독일
- Chiesi Clinical Trial Site 276711
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Frankfurt am Main, 독일
- Chiesi Clinical Trial Site 276707
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Frankfurt am Main, 독일
- Chiesi Clinical Trial Site 276714
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Hamburg, 독일
- Chiesi Clinical Trial Site 276705
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Hanover, 독일
- Chiesi Clinical Trial Site 276703
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Koblenz, 독일
- Chiesi Clinical Trial Site 276708
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Leipzig, 독일
- Chiesi Clinical Trial Site 276702
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Leipzig, 독일
- Chiesi Clinical Trial Site 276704
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Leipzig, 독일
- Chiesi Clinical Trial Site 276710
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Mainz, 독일
- Chiesi Clinical Trial Site 276715
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München, 독일
- Chiesi Clinical Trial Site 276701
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Münster, 독일
- Chiesi Clinical Trial Site 276713
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Rosenheim, 독일
- Chiesi Clinical Trial Site 276716
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Chelyabinsk, 러시아 제국
- Chiesi Clinical Trial Site 643727
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Chelyabinsk, 러시아 제국
- Chiesi Clinical Trial Site 643733
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Chelyabinsk, 러시아 제국
- Chiesi Clinical Trial Site 643745
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Izhevsk, 러시아 제국
- Chiesi Clinical Trial Site 643754
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Kazan', 러시아 제국
- Chiesi Clinical Trial Site 643713
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Kazan', 러시아 제국
- Chiesi Clinical Trial Site 643719
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Kazan', 러시아 제국
- Chiesi Clinical Trial Site 643741
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Kazan', 러시아 제국
- Chiesi Clinical Trial Site 643746
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Kemerovo, 러시아 제국
- Chiesi Clinical Trial Site 643704
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Kemerovo, 러시아 제국
- Chiesi Clinical Trial Site 643731
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643702
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643705
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643706
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643718
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643722
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643735
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Moscow, 러시아 제국
- Chiesi Clinical Trial Site 643743
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Nizhny Novgorod, 러시아 제국
- Chiesi Clinical Trial Site 643707
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Nizhny Novgorod, 러시아 제국
- Chiesi Clinical Trial Site 643723
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Nizhny Novgorod, 러시아 제국
- Chiesi Clinical Trial Site 643744
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Novosibirsk, 러시아 제국
- Chiesi Clinical Trial Site 643717
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Odintsovo, 러시아 제국
- Chiesi Clinical Trial Site 643724
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Orenburg, 러시아 제국
- Chiesi Clinical Trial Site 643729
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Pyatigorsk, 러시아 제국
- Chiesi Clinical Trial Site 643711
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Ryazan, 러시아 제국
- Chiesi Clinical Trial Site 643701
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643712
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643714
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643715
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643716
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643725
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643730
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643732
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643737
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643739
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643752
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643757
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Saint Petersburg, 러시아 제국
- Chiesi Clinical Trial Site 643758
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Saratov, 러시아 제국
- Chiesi Clinical Trial Site 643703
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Saratov, 러시아 제국
- Chiesi Clinical Trial Site 643736
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Smolensk, 러시아 제국
- Chiesi Clinical Trial Site 643726
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Stavropol, 러시아 제국
- Chiesi Clinical Trial Site 643740
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Tomsk, 러시아 제국
- Chiesi Clinical Trial Site 643709
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Tomsk, 러시아 제국
- Chiesi Clinical Trial Site 643728
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Tomsk, 러시아 제국
- Chiesi Clinical Trial Site 643759
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Ufa, 러시아 제국
- Chiesi Clinical Trial Site 643755
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Vladikavkaz, 러시아 제국
- Chiesi Clinical Trial Site 643708
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Vladimir, 러시아 제국
- Chiesi Clinical Trial Site 643738
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Voronezh, 러시아 제국
- Chiesi Clinical Trial Site 643710
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Yaroslavl, 러시아 제국
- Chiesi Clinical Trial Site 643720
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Yaroslavl, 러시아 제국
- Chiesi Clinical Trial Site 643734
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Yaroslavl, 러시아 제국
- Chiesi Clinical Trial Site 643742
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Yaroslavl, 러시아 제국
- Chiesi Clinical Trial Site 643749
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Yekaterinburg, 러시아 제국
- Chiesi Clinical Trial Site 643721
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Alexandru cel Bun, 루마니아
- Chiesi Clinical Trial Site 642715
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Arad, 루마니아
- Chiesi Clinical Trial Site 642713
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Bacau, 루마니아
- Chiesi Clinical Trial Site 642722
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Bragadiru, 루마니아
- Chiesi Clinical Trial Site 642717
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Brasov, 루마니아
- Chiesi Clinical Trial Site 642706
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Bucharest, 루마니아
- Chiesi Clinical Trial Site 642703
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Bucharest, 루마니아
- Chiesi Clinical Trial Site 642707
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Bucharest, 루마니아
- Chiesi Clinical Trial Site 642708
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Bucharest, 루마니아
- Chiesi Clinical Trial Site 642719
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Bucharest, 루마니아
- Chiesi Clinical Trial Site 642723
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Cluj-Napoca, 루마니아
- Chiesi Clinical Trial Site 642709
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Cluj-Napoca, 루마니아
- Chiesi Clinical Trial Site 642714
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Cluj-Napoca, 루마니아
- Chiesi Clinical Trial Site 642716
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Cluj-Napoca, 루마니아
- Chiesi Clinical Trial Site 642718
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Cluj-Napoca, 루마니아
- Chiesi Clinical Trial Site 642726
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Craiova, 루마니아
- Chiesi Clinical Trial Site 642712
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Iași, 루마니아
- Chiesi Clinical Trial Site 642704
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Iași, 루마니아
- Chiesi Clinical Trial Site 642710
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Oradea, 루마니아
- Chiesi Clinical Trial Site 642705
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Suceava, 루마니아
- Chiesi Clinical Trial Site 642711
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Timișoara, 루마니아
- Chiesi Clinical Trial Site 642721
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Vilnius, 리투아니아
- Chiesi Clinical Trial Site 440702
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Vilnius, 리투아니아
- Chiesi Clinical Trial Site 440703
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Vilnius, 리투아니아
- Chiesi Clinical Trial Site 440705
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Šiauliai, 리투아니아
- Chiesi Clinical Trial Site 440701
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Homyel, 벨라루스
- Chiesi Clinical Trial Site 112703
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Homyel, 벨라루스
- Chiesi Clinical Trial Site 112704
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Minsk, 벨라루스
- Chiesi Clinical Trial Site 112701
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Minsk, 벨라루스
- Chiesi Clinical Trial Site 112702
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Minsk, 벨라루스
- Chiesi Clinical Trial Site 112705
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Blagoevgrad, 불가리아
- Chiesi Clinical Trial Site 100707
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Burgas, 불가리아
- Chiesi Clinical Trial Site 100720
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Gabrovo, 불가리아
- Chiesi Clinical Trial Site 100718
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Haskovo, 불가리아
- Chiesi Clinical Trial Site 100713
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Montana, 불가리아
- Chiesi Clinical Trial Site 100722
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Pleven, 불가리아
- Chiesi Clinical Trial Site 100702
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Plovdiv, 불가리아
- Chiesi Clinical Trial Site 100705
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Plovdiv, 불가리아
- Chiesi Clinical Trial Site 100708
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Plovdiv, 불가리아
- Chiesi Clinical Trial Site 100715
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Rousse, 불가리아
- Chiesi Clinical Trial Site 100716
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Sofia, 불가리아
- Chiesi Clinical Trial Site 100701
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Sofia, 불가리아
- Chiesi Clinical Trial Site 100703
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Sofia, 불가리아
- Chiesi Clinical Trial Site 100704
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Sofia, 불가리아
- Chiesi Clinical Trial Site 100709
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Sofia, 불가리아
- Chiesi Clinical Trial Site 100719
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Stara Zagora, 불가리아
- Chiesi Clinical Trial Site 100706
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Stara Zagora, 불가리아
- Chiesi Clinical Trial Site 100712
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Varna, 불가리아
- Chiesi Clinical Trial Site 100710
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Vidin, 불가리아
- Chiesi Clinical Trial Site 100711
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Vidin, 불가리아
- Chiesi Clinical Trial Site 100721
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A Coruña, 스페인
- Chiesi Clinical Trial Site 724702
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Badajoz, 스페인
- Chiesi Clinical Trial Site 724703
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Badalona, 스페인
- Chiesi Clinical Trial Site 724706
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Madrid, 스페인
- Chiesi Clinical Trial Site 724701
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Madrid, 스페인
- Chiesi Clinical Trial Site 724704
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Málaga, 스페인
- Chiesi Clinical Trial Site 724705
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Sabadell, 스페인
- Chiesi Clinical Trial Site 724707
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Bratislava, 슬로바키아
- Chiesi Clinical Trial Site 703704
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Bratislava, 슬로바키아
- Chiesi Clinical Trial Site 703707
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Ilava, 슬로바키아
- Chiesi Clinical Trial Site 703702
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Košice, 슬로바키아
- Chiesi Clinical Trial Site 703705
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Košice, 슬로바키아
- Chiesi Clinical Trial Site 703706
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Nové Zámky, 슬로바키아
- Chiesi Clinical Trial Site 703701
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Prievidza, 슬로바키아
- Chiesi Clinical Trial Site 703709
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Spišská Nová Ves, 슬로바키아
- Chiesi Clinical Trial Site 703703
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Štúrovo, 슬로바키아
- Chiesi Clinical Trial Site 703708
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Buenos Aires, 아르헨티나
- Chiesi Clinical Trial Site 432702
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CABA, 아르헨티나
- Chiesi Clinical Trial Site 432704
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Mar del Plata, 아르헨티나
- Chiesi Clinical Trial Site 432705
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Quilmes, 아르헨티나
- Chiesi Clinical Trial Site 432701
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San Miguel de Tucumán, 아르헨티나
- Chiesi Clinical Trial Site 432703
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San Miguel de Tucumán, 아르헨티나
- Chiesi Clinical Trial Site 432706
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Llanelli, 영국
- Chiesi Clinical Trial Site 826702
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London, 영국
- Chiesi Clinical Trial Site 826703
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Manchester, 영국
- Chiesi Clinical Trial Site 826704
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Soham, 영국
- Chiesi Clinical Trial Site 826701
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Dnipro, 우크라이나
- Chiesi Clinical Trial Site 804701
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Ivano-Frankivsk, 우크라이나
- Chiesi Clinical Trial Site 804711
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Kharkiv, 우크라이나
- Chiesi Clinical Trial Site 804709
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Kherson, 우크라이나
- Chiesi Clinical Trial Site 804710
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Kiev, 우크라이나
- Chiesi Clinical Trial Site 804713
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Kyiv, 우크라이나
- Chiesi Clinical Trial Site 804705
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Lviv, 우크라이나
- Chiesi Clinical Trial Site 804712
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Sumy, 우크라이나
- Chiesi Clinical Trial Site 804715
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Vinnytsia, 우크라이나
- Chiesi Clinical Trial Site 804703
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Vinnytsia, 우크라이나
- Chiesi Clinical Trial Site 804706
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Vinnytsia, 우크라이나
- Chiesi Clinical Trial Site 804707
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Vinnytsia, 우크라이나
- Chiesi Clinical Trial Site 804714
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Zaporizhzhya, 우크라이나
- Chiesi Clinical Trial Site 804704
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Zhytomyr, 우크라이나
- Chiesi Clinical Trial Site 804708
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Bologna, 이탈리아
- Chiesi Clinical Trial Site 380704
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Catania, 이탈리아
- Chiesi Clinical Trial Site 380703
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Genova, 이탈리아
- Chiesi Clinical Trial Site 380701
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Palermo, 이탈리아
- Chiesi Clinical Trial Site 380705
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Pavia, 이탈리아
- Chiesi Clinical Trial Site 380702
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Tradate, 이탈리아
- Chiesi Clinical Trial Site 380706
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Blansko, 체코
- Chiesi Clinical Trial Site 203711
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Brandýs nad Labem, 체코
- Chiesi Clinical Trial Site 203702
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Brno, 체코
- Chiesi Clinical Trial Site 203708
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Jindřichův Hradec, 체코
- Chiesi Clinical Trial Site 203707
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Kralupy nad Vltavou, 체코
- Chiesi Clinical Trial Site 203705
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Miroslav, 체코
- Chiesi Clinical Trial Site 203709
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Opava, 체코
- Chiesi Clinical Trial Site 203704
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Prague, 체코
- Chiesi Clinical Trial Site 203701
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Prague, 체코
- Chiesi Clinical Trial Site 203703
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Prague, 체코
- Chiesi Clinical Trial Site 203710
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Rokycany, 체코
- Chiesi Clinical Trial Site 203713
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Teplice, 체코
- Chiesi Clinical Trial Site 203706
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Varnsdorf, 체코
- Chiesi Clinical Trial Site 203712
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Ankara, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792701
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Ankara, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792702
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Antalya, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792703
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Aydin, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792710
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Istanbul, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792707
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Kocaeli, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792706
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Maltepe, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792705
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Mersin, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792708
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Yenişehir, 터키 (Türkiye)
- Chiesi Clinical Trial Site 792709
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Aveiro, 포르투갈
- Chiesi Clinical Trial Site 620704
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Figueira da Foz Municipality, 포르투갈
- Chiesi Clinical Trial Site 620703
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Lisbon, 포르투갈
- Chiesi Clinical Trial Site 620702
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Loures, 포르투갈
- Chiesi Clinical Trial Site 620708
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Vila Nova de Gaia, 포르투갈
- Chiesi Clinical Trial Site 620707
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Bialystok, 폴란드
- Chiesi Clinical Trial Site 616713
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Bialystok, 폴란드
- Chiesi Clinical Trial Site 616718
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Bielsko-Biala, 폴란드
- Chiesi Clinical Trial Site 616722
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Bienkówka, 폴란드
- Chiesi Clinical Trial Site 616702
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Bydgoszcz, 폴란드
- Chiesi Clinical Trial Site 616727
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Giżycko, 폴란드
- Chiesi Clinical Trial Site 616704
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Grudziądz, 폴란드
- Chiesi Clinical Trial Site 616716
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Katowice, 폴란드
- Chiesi Clinical Trial Site 616725
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Katowice, 폴란드
- Chiesi Clinical Trial Site 616729
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Krakow, 폴란드
- Chiesi Clinical Trial Site 616719
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Krakow, 폴란드
- Chiesi Clinical Trial Site 616734
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Krakow, 폴란드
- Chiesi Clinical Trial Site 616736
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Lodz, 폴란드
- Chiesi Clinical Trial Site 616707
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Lodz, 폴란드
- Chiesi Clinical Trial Site 616708
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Lodz, 폴란드
- Chiesi Clinical Trial Site 616711
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Lodz, 폴란드
- Chiesi Clinical Trial Site 616726
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Mrozy, 폴란드
- Chiesi Clinical Trial Site 616733
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Ostróda, 폴란드
- Chiesi Clinical Trial Site 616717
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Otwock, 폴란드
- Chiesi Clinical Trial Site 616731
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Pabianice, 폴란드
- Chiesi Clinical Trial Site 616703
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Poznan, 폴란드
- Chiesi Clinical Trial Site 616709
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Poznan, 폴란드
- Chiesi Clinical Trial Site 616728
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Proszowice, 폴란드
- Chiesi Clinical Trial Site 616720
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Rzeszów, 폴란드
- Chiesi Clinical Trial Site 616723
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Rzeszów, 폴란드
- Chiesi Clinical Trial Site 616735
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Skierniewice, 폴란드
- Chiesi Clinical Trial Site 616721
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Strzelce Opolskie, 폴란드
- Chiesi Clinical Trial Site 616732
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Tarnów, 폴란드
- Chiesi Clinical Trial Site 616710
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Warsaw, 폴란드
- Chiesi Clinical Trial Site 616701
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Wilkowice, 폴란드
- Chiesi Clinical Trial Site 616730
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Wroclaw, 폴란드
- Chiesi Clinical Trial Site 616705
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Wroclaw, 폴란드
- Chiesi Clinical Trial Site 616714
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Wroclaw, 폴란드
- Chiesi Clinical Trial Site 616715
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Świdnik, 폴란드
- Chiesi Clinical Trial Site 616712
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Balassagyarmat, 헝가리
- Chiesi Clinical Trial Site 348707
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Budapest, 헝가리
- Chiesi Clinical Trial Site 348715
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Debrecen, 헝가리
- Chiesi Clinical Trial Site 348721
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Gödöllő, 헝가리
- Chiesi Clinical Trial Site 348712
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Hatvan, 헝가리
- Chiesi Clinical Trial Site 348718
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Komárom, 헝가리
- Chiesi Clinical Trial Site 348717
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Létavértes, 헝가리
- Chiesi Clinical Trial Site 348709
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Monor, 헝가리
- Chiesi Clinical Trial Site 348703
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Mórahalom, 헝가리
- Chiesi Clinical Trial Site 348719
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Nyíregyháza, 헝가리
- Chiesi Clinical Trial Site 348704
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Nyíregyháza, 헝가리
- Chiesi Clinical Trial Site 348714
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Pécs, 헝가리
- Chiesi Clinical Trial Site 348713
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Pécs, 헝가리
- Chiesi Clinical Trial Site 348720
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Siófok, 헝가리
- Chiesi Clinical Trial Site 348702
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Szarvas, 헝가리
- Chiesi Clinical Trial Site 348706
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Szeged, 헝가리
- Chiesi Clinical Trial Site 348701
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Szombathely, 헝가리
- Chiesi Clinical Trial Site 348705
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Vásárosnamény, 헝가리
- Chiesi Clinical Trial Site 348710
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Érd, 헝가리
- Chiesi Clinical Trial Site 348708
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 천식 병력이 1년 이상이고 40세 이전에 진단받은 자
- ACQ-7(천식 조절 설문지) ≥1.5와 함께 LABA(Long-Acting Beta2 Agonist)와 병용하여 고용량의 흡입 코르티코스테로이드(ICS)만 사용하는 이중 요법으로 조절되지 않는 천식
- 기관지 확장제 사용 전 FEV1 < 예측 정상 값의 80%
- 양성 가역성 테스트
- 전년도에 최소 1건의 문서화된 천식 악화
제외 기준:
- 임산부 또는 수유부
- 만성폐쇄성폐질환(COPD)의 진단
- 스크리닝 전 4주 동안 천식 악화 또는 호흡기 감염이 있는 환자
- 현재 흡연자 또는 과거 흡연자(>= 연간 10갑)
- 스크리닝 전 4주 동안 ICS + LABA 조합의 용량, 일정 또는 제형의 모든 변경
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CHF 5993 200/6/12.5µg
치료 A: CHF 5993 200/6/12.5 µg: 2회 흡입 총 일일 복용량: 800/24/50 µg BDP/FF/GB |
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활성 비교기: CHF 1535 200/6µg
치료 B: CHF 1535 200/6µg: 2회 흡입 입찰 일일 총 투여량: 800/24µg BDP/FF |
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활성 비교기: CHF 1535 200/6µg + Tiotropium Respimat 2.5µg
치료 C(개방 라벨 부문): CHF 1535 200/6µg: 2회 흡입 입찰 + Tiotropium Respimat 2.5µg: 2회 흡입 od 총 일일 용량: 800/24µg BDP/FF + 5µg Tio |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
기간: Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26.
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2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations). Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
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Week 0 (pre-treatment, baseline) to Week 52.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
기간: Week 0 (pre-treatment, baseline) and Week 26.
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Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) and Week 26.
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4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
기간: Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26). PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26.
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5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
기간: The entire treatment period; up to Week 52.
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Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
The entire treatment period; up to Week 52.
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6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
기간: Week 0 (pre-treatment, baseline) to Week 52.
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The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits. Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
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7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in pre-dose FEV1 at all clinical visits. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
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8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52. The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2). Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose). FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
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10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
기간: Week 0 (pre-treatment, baseline) to Week 52.
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ACQ-7 Questionnaire. ACQ-7 allows assessment of asthma control in individual patients. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function. |
Week 0 (pre-treatment, baseline) to Week 52.
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11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above. An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data. Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment. PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 52.
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12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment. PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Number of patients at risk of a moderate or severe asthma exacerbation. Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period. |
Week 0 (pre-treatment, baseline) to Week 52.
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14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
기간: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
기간: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
기간: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
기간: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
기간: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
기간: Week 0 (pre-treatment, baseline) to Week 52.
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MODERATE asthma exacerbation rate over the 52-Week treatment period. Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
|
Week 0 (pre-treatment, baseline) to Week 52.
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20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
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Week 0 (pre-treatment, baseline) to Week 52.
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21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods. Data was collected using an electronic daily diary, from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness. Morning (night-time asthma symptom score):
Evening (daytime asthma symptom score):
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Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
기간: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness. Morning (night-time asthma symptom score):
Evening (daytime asthma symptom score):
|
Week 0 (pre-treatment, baseline) to Week 52.
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24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
기간: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment. Data was collected through an electronic daily diary from screening to end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
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25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
기간: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
기간: Week 0 (pre-treatment, baseline) to Week 52.
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A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/ take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
부작용 및 약물 부작용
기간: 52주까지
|
52주까지
|
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건강 경제학 결과 수집
기간: 0주차 ~ 52주차
|
의료 자원의 총 사용 및 결근
|
0주차 ~ 52주차
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Georgio Walter Canonica, MD, University of Medicine, Genoa, Italy
간행물 및 유용한 링크
일반 간행물
- Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
- Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.
- Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
유용한 링크
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB2-02; TRIGGER;
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB1-03; TRIMARAN
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN) ClinicalTrials.gov ID NCT02676076
- TRIple in Asthma hiGh strenGth vErsus Ics/ Laba hs and tiotRopium (TRIGGER)
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCD-05993AB2-02
- 2015-000717-40 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Chiesi는 적법한 연구, 환자 수준 데이터, 연구 수준 데이터, 임상 프로토콜 및 전체 CSR을 수행하여 자격을 갖춘 과학 및 의료 연구원과 공유하고 상업적으로 기밀 정보와 환자를 보호한다는 원칙에 따라 임상 시험 정보에 대한 액세스를 제공합니다. 은둔. 공유된 모든 환자 수준 데이터는 개인 식별 정보를 보호하기 위해 익명으로 처리됩니다.
Chiesi 액세스 기준 및 임상 데이터 공유를 위한 전체 프로세스는 Chiesi Group 웹사이트에서 확인할 수 있습니다.
IPD 공유 기간
See information above in Plan Description regarding Chiesi's commitment to share information with qualified scientific and medical researchers, conducting legitimate research
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD 공유 액세스 기준
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
CHF 5993 200/6/12.5µg에 대한 임상 시험
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Chiesi Farmaceutici S.p.A.아직 모집하지 않음
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Chiesi Farmaceutici S.p.A.SGS S.A.완전한
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Chiesi Farmaceutici S.p.A.완전한