A Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.

This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study was intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.

开始日期2012-08-01

申办/合作机构

Grifols Therapeutics, Inc.

100 项与 Alpha-1-antitrypsin inhalation(Bayer AG) 相关的临床结果

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100 项与 Alpha-1-antitrypsin inhalation(Bayer AG) 相关的转化医学

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100 项与 Alpha-1-antitrypsin inhalation(Bayer AG) 相关的专利（医药）

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项与 Alpha-1-antitrypsin inhalation(Bayer AG) 相关的文献（医药）

2016-03-01·Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2区 · 医学

Inhaled alpha 1 -proteinase inhibitor therapy in patients with cystic fibrosis

2区 · 医学

Article

作者: Nichols, David ; Griffin, Rhonda ; Gaggar, Amit ; Chmiel, James F ; Dorkin, Henry L ; Flume, Patrick A ; Donaldson, Scott H ; Chen, Junliang

BACKGROUND:

Inhaled alpha1-proteinase inhibitor (PI) is known to reduce neutrophil elastase burden in some patients with CF. This phase 2a study was designed to test inhaled Alpha-1 HC, a new aerosolized alpha1-PI formulation, in CF patients.

METHODS:

We performed a randomized, double-blind, placebo-controlled study and evaluated the safety of 100 or 200mg of inhaled Alpha-1 HC once daily for 3 weeks in subjects with CF. Thirty adult subjects were randomized in a 2:1 ratio to receive Alpha-1 HC or placebo.

RESULTS:

Drug delivery was confirmed by a dose-dependent increase in the sputum alpha1-PI. Seven (20.0%) of the 35 adverse events in the 100-mg dose group, 3 (13.0%) of 23 in the 200-mg dose group, and 4 (14.3%) of 28 in the placebo group were drug-related in these subjects. One serious adverse event occurred in 1 subject within each group.

CONCLUSIONS:

Alpha-1 HC inhalation was safe and well tolerated.

100 项与 Alpha-1-antitrypsin inhalation(Bayer AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Alpha-1-antitrypsin inhalation(Bayer AG)	-	DB05481

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
囊性纤维化	临床2期	美国	Grifols Therapeutics, Inc.	2012-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01684410 (CTgov)	临床2期	囊性纤维化	30	Alpha-1 HC 100 mg (Alpha-1 HC 100 mg)	遞膚構鹽齋遞繭鑰選夢 = 夢遞淵壓齋餘遞膚鏇淵廠鏇蓋醖簾鏇範廠鏇夢 (觸構衊鏇築獵膚膚築製, 餘積鹹製夢夢遞簾窪鑰 ~ 遞蓋蓋襯顧蓋蓋膚淵鏇) 更多	-	2016-02-08
				Alpha-1 HC 200 mg (Alpha-1 HC 200 mg)	遞膚構鹽齋遞繭鑰選夢 = 窪製齋糧鑰膚鹹鏇積衊廠鏇蓋醖簾鏇範廠鏇夢 (觸構衊鏇築獵膚膚築製, 膚簾壓網壓鑰淵襯艱鑰 ~ 顧鏇醖衊願網艱遞鬱夢) 更多