Aclidinium for use in improving the quality of sleep in respiratory patients

• US 9,737,520 B2
• Filed: 05/23/2016
• Issued: 08/22/2017
• Est. Priority Date: 04/15/2011
• Status: Active Grant

• Current Assignee: Almirall, S.A. (Grupo Corporativo Landon SL)
• Original Assignee: Almirall, S.A. (Grupo Corporativo Landon SL)
• Inventors: Garcia Gil, Maria Esther, De Miquel Serra, Gonzalo, Sala Peinado, Maria Jose
• Primary Examiner(s): RAO, SAVITHA M
• Application Number:
  US15/161,531
• Publication Number:
  US 20160263091A1
• Time in Patent Office: 456 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/439 the ring forming part of a bridged ring system, e.g. quinuclidine 8-azabicyclo [3.2.1] octanes A61K31/46
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present disclosure provides aclidinium or any of its stereoisomers or mixture of stereoisomers, or a pharmaceutically acceptable salt or solvate thereof, for improving the quality of sleep in respiratory patients.

Claims

1. A method for improving the quality of sleep in a respiratory patient experiencing sleep disturbances, comprising:

administering to the patient a pharmaceutical composition comprising aclidinium or any of its stereoisomers or mixture of stereoisomers, or a pharmaceutically acceptable salt or solvate thereof.

2. The method according to claim 1, wherein the aclidinium is in the form of aclidinium bromide.

3. The method according to claim 1, wherein the respiratory patient suffers from asthma or chronic obstructive pulmonary disease (COPD).

4. The method according to claim 1, wherein the aclidinium is in the form of a dry powder formulation suitable for inhalation.

5. The method for use in a dry powder formulation according to claim 4, providing a metered nominal dose of aclidinium equivalent to from 100 to 1000 micrograms of aclidinium bromide per inhalation.

6. The method according to claim 5, wherein the metered nominal dose of aclidinium is equivalent to 200 micrograms of aclidinium bromide per inhalation.

7. The method according to claim 5, wherein the metered nominal dose of aclidinium is equivalent to 400 micrograms of aclidinium bromide per inhalation.

8. The method according to claim 1, wherein aclidinium is administered at least once per day.

9. The method according to claim 8, wherein aclidinium is administered twice daily.

10. The method according to claim 1, wherein aclidinium is co-administered with a therapeutically effective amount of at least one other medication chosen from corticosteroids, beta-adrenergic agonists, and PDE4 inhibitors.

11. The method according to claim 1, wherein the quality of sleep is improved by reducing at least one of the following sleep disturbances:

a) latency to falling asleep;

b) total number of awakenings;

c) early awakenings;

d) difficulty in staying asleep;

e) superficial sleep;

f) insomnia;

g) daytime sleepiness or fatigue;

h) restriction of activities during the morning;

and/or by increasing total sleep time.

12. The method according to claim 1, wherein the pharmaceutical composition comprises aclidinium in an effective amount of aclidinium.

13. The method according to claim 1, wherein the patient suffers from a respiratory disorder and wherein the patient suffers from impaired sleep caused by sleep disturbances.

14. The method according to claim 13, wherein the patient suffers from asthma or chronic obstructive pulmonary disease.

15. The method according to claim 5, wherein the formulation is administered in a dosage comprising an amount of aclidinium ranging from 200 micrograms to 400 micrograms of aclidinium bromide per inhalation.