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Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease

A composition, the technology of aclidinium bromide, applied in the field of treating respiratory diseases, can solve the problems such as the dosage has not been disclosed yet

Inactive Publication Date: 2011-06-01
ALMIRALL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this compound is known as a long-acting anticholinergic drug and is helpful in the treatment of respiratory diseases, the optimal dosage has not yet been revealed

Method used

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  • Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease

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Experimental program
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Effect test

example 1

[0042] METHODS: Patients with moderate to severe long-term COPD were randomized to receive a double blind, once-daily adenia (25, 50, 100, 200 or 400 micrograms) over four weeks plus Treatment, placebo or overtly labeled tiotropium 18 micrograms. Spirometric measurements were performed as follows: 22 to 24 hours after the first dose and weekly thereafter, and 0.5 to 6 hours after the first dose and at the fourth week (Day 29) .

[0043] RESULTS: The ITT population included 460 patients. On Day 29, the dose-related increase in FEV with Adenia is listed in the table below 1 valley (trough FEV 1 ).

[0044] Day 29FEV 1 average change from trough baseline

[0045]

[0046] * p<0.05 vs placebo

[0047]Unlike tiotropium, Adenia had bronchodilation comparable to day 1 (for all doses) within the first 6 hours after dosing on day 29. For 100 to 400 mcg of adenia, FEV was achieved 3 hours after dosing 1 The peak value (peak FEV 1 ). Adenia was well tolerated, and the use ...

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Abstract

A pharmaceutical composition for inhalation comprises aclidinium in the form of a dry powder of a pharmaceutically acceptable salt in admixture with a pharmaceutically acceptable dry powder carrier, and provides a metered nominal dose of aclidinium equivalent to about 400 mg aclidinium bromide.

Description

technical field [0001] The present invention relates to a novel dose of aclidinium and a novel method and formulation of using aclidinium to treat respiratory diseases, especially asthma and chronic obstructive pulmonary disease. Background technique [0002] Aclidinium bromide (aclidinium bromide) is (3R)-(2-hydroxyl-2,2-dithiophen-2-ylacetoxy)-1-(3-phenoxypropyl)-1-azabicyclo[ 2.2.2] Octane bromide (ie described eg in WO0104118). Although this compound is known as a long-acting anticholinergic drug and is helpful in the treatment of respiratory diseases, its optimal dosage has not yet been revealed. Contents of the invention [0003] Surprisingly, in the results of the present study, it was found that the most effective way to use Adenia in the treatment of adults with respiratory diseases, especially asthma and chronic obstructive pulmonary disease, is to use the inhalation method to give each dose of the standard dose in one dose. Adenia in a metered nominal dose of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/72A61K31/46A61K45/06A61K9/00
CPCA61K45/06A61K31/439A61K31/167A61K31/46A61K9/0075A61P11/00A61P11/06A61P11/08A61K2300/00A61K9/145A61K9/14A61K2121/00
Inventor 罗莎·拉马尔卡卡萨多贡萨洛·德米克尔塞拉
Owner ALMIRALL