Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations

Abstract

A method is provided for improving lung function in COPD by administering a muscarinic antagonist with a high efficiency nebulizer.

Description

[0001]This application claims priority under 35 U.S.C. §120 from U.S. nonprovisional patent application Ser. No. 12 / 393,709, filed Feb. 26, 2009, and claims priority under 35 U.S.C. §119(e) from U.S. provisional patent application 61 / 031,639, filed Feb. 26, 2008, and from U.S. provisional patent application 61 / 080,184, filed Jul. 11, 2008, each of which applications is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]Chronic obstructive airway disease (COPD) is a pulmonary (lung) disease characterized by chronic obstruction of the airways. COPD encompasses emphysema and chronic bronchitis. Chronic bronchitis is diagnosed where a patient suffers from chronic cough, mucus production, or both, for at least three months in at least two successive years where other causes of chronic cough have been excluded. In chronic bronchitis, airway obstruction is caused by chronic and excessive secretion of abnormal airway mucus, inflammation, and bronchospasm. Ofte...

AI Technical Summary

Benefits of technology

[0015]Some embodiments described herein provide a method of treating a patient having chronic obstructive pulmonary disease (COPD), comprising administering to the patient, with a high efficiency nebulizer, a composition comprising a muscarinic antagonist that provides to the patient a respirable dose or deposited dose of a muscarinic antagonist, wherein achievement of said respirable dose or deposited dose with said high efficiency nebulizer provides to the patient: (1) a similar or an increased magnitude and/or duration of therapeutic effect; and (2) reduced or acceptable side effects, compared to achievement of the same respirable dose or deposited dose of the muscarinic antagonist with a conventional nebulizer. In some embodiments, achievement of the respirable dose or deposited dose with the high efficiency nebulizer produces in the patient an increased duration of therapeutic effect of at least 24 hours after administration of the nominal dose. In some embodiments, the therapeutic effect comprises an improvement of FEV1 of at least about 100 mL above baseline when adjusted for placebo or at least about 10% above baseline, when adjusted for placebo, 24 hours after the composition is administered with the high efficiency nebulizer.

[0016]Some embodiments described herein provide a method of treating a patient having chronic obstructive pulmonary disease (COPD), comprising administering to the patient, with a nebulizer, a dose of glycopyrrolate, wherein the administration produces in the patient an area und

Problems solved by technology

Emphysema involves the destruction of elastin in terminal bronchioles, which leads to remodeling, destruction and ultimate collapse of the airway walls.

Patients with emphysema gradually lose the ability to exhale, causing a rise in blood waste gasses (such as carbon dioxide), a drop in blood oxygen, and a general degradation of patient stamina and overall health.

While most patients respond to treatment with metered dose inhalers or dry powder inhalers, there is a subset of patients for whom such options are not well-suited.

Older and sicker COPD patients, for example, often find it difficult to use, or do not experience therapeutic benefit from the use of, metered dose inhalers or dry powder inhalers.

Patients whose motor skills are impaired or not fully developed will often have trouble activating the device, coordinating their breathing, and generally using metered dose inhalers.

Patients who also have poor inhalation capacity and control find dry powder inhalers to be difficult to operate as well.

The '607 patent distinguishes this methodology from administration of a solution formulation of glycopyrrolate, which is characterized as being unable to achieve effective treatment of COPD for longer than 12 hours.

Although the bronchoprotective effect in response to a bronchial challenge test is considered a useful surrogate t

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