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08/24/06 - USPTO Class 514 |  54 views | #20060189587 | Prev - Next | About this Page  514 rss/xml feed  monitor keywords

Use for budesonide and formoterol

USPTO Application #: 20060189587
Title: Use for budesonide and formoterol
Abstract: The invention provides the use of formoterol and budesonide in the treatment of chronic obstructive pulmonary disease. (end of abstract)



Agent: Fish & Richardson PC - Minneapolis, MN, US
Inventors: Carl-Axel Bauer, Jan Trofast
USPTO Applicaton #: 20060189587 - Class: 514171000 (USPTO)

Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Cyclopentanohydrophenanthrene Ring System Doai, With Additional Active Ingredient

Use for budesonide and formoterol description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060189587, Use for budesonide and formoterol.

Brief Patent Description - Full Patent Description - Patent Application Claims
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FIELD OF THE INVENTION

[0001] The invention provides the use of formoterol and budesonide in the treatment of chronic obstructive pulmonary disease (COPD).

BACKGROUND OF THE INVENTION

[0002] Chronic obstructive pulmonary disease (COPD) is a term which refers to a large group of lung diseases which can interfere with normal breathing. It is estimated that 11% of the U.S. population has COPD and the incidence is increasing. The two most important conditions covered by COPD are chronic bronchitis and emphysema.

[0003] Chronic bronchitis is a long-standing inflammation of the bronchi which causes increased production of mucous and other changes. The patients' symptoms are cough and expectoration of sputum. Chronic bronchitis can lead to more frequent and severe respiratory infections, narrowing and plugging of the bronchi, difficult breathing and disability.

[0004] Emphysema is a chronic lung disease which affects the alveoli and/or the ends of the smallest bronchi. The lung loses its elasticity and therefore these areas of the lungs become enlarged. These enlarged areas trap stale air and do not effectively exchange it with fresh air. This results in difficult breathing and may result in insufficient oxygen being delivered to the blood. The predominant symptom in patients with emphysema is shortness of breath.

[0005] At present moderate to severe COPD is treated with a variety of monotherapies including inhaled or orally administered bronchodilators, inhaled anti-cholinergic agents and orally administered steroids, especially corticosteroids. The problem with these treatments is that none of them is especially effective. For example, many patients with COPD have a reversible component. Accordingly a new treatment is required for decreasing the intensity of exacerbations, thereby improving the lung function of patients suffering from COPD.

DESCRIPTION OF THE INVENTION

[0006] It has surprisingly been found that the combination of formoterol and budesonide is effective in treating COPD.

[0007] The combination of budesonide and formoterol reduces the number of exacerbations of COPD compared to the monotherapies using budesonide or formoterol, thereby improving the lung function of the patients. Thus, the combination of budesonide and forrmoterol will give greater compliance, greater efficacy, less exacerbations and/or better sleep.

[0008] The present invention also gives an increased compliance and efficacy and thereby quality of life.

[0009] According to the invention there is provided the use of a composition comprising, in admixture or separately:

[0010] (a) a first active ingredient which is formoterol, a pharmaceutically acceptable salt or solvate thereof, or a solvate of such a salt;

[0011] (b) a second active ingredient which is budesonide; and

a molar ratio of the first active ingredient to the second active ingredient of from 1:2500 to 12:1, in the manufacture of a medicament for use in the treatment of chronic obstructive pulmonary disease.

[0012] The composition used in the invention optionally additionally comprises one or more pharmaceutically acceptable additives, diluents and/or carriers. The composition is preferably in the form of a dry powder, wherein the particles of the pharmaceutically active ingredients preferably have a mass median diameter of less than 10 .mu.m.

[0013] The invention also includes the use of a kit containing:

[0014] (i) a vessel containing the first active ingredient;

[0015] (ii) a vessel containing the second active ingredient;

[0016] (iii) a molar ratio of the first active ingredient to the second active ingredient of from 1:2500 to 12:1; and

[0017] (iv) instructions for the simultaneous, sequential or separate administration of the active ingredients to a patient in need thereof;

in the manufacture of a medicament for use in the treatment of chronic obstructive pulmonary disease.

[0018] A patient suffering from COPD can be treated by administering via inhalation a composition as defined above. Alternatively such a patient can be treated by administering via inhalation, simultaneously, sequentially or separately, (i) a dose of the first active ingredient; and (ii) a dose of the second active ingredient. The molar ratio of the first active ingredient to the second active ingredient is from 1:2500 to 12. The doses can be provided to the patient for inhalation in dry powder form.

[0019] The invention further provides the use of budesonide and of formoterol in the manufacture of a composition or a kit, as used in the invention, for use in the treatment of chronic obstructive pulmonary disease.

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