Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
2001-08-15
2003-01-21
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C514S343000, C514S825000, C514S853000
Reexamination Certificate
active
06509043
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to soy protein, phytoestrogens and dietary fibres and compositions thereof suitable for preventing, alleviating and/or treating pulmonary diseases. The compositions are particularly useful in treating e.g. chronic obstructive pulmonary disease (COPD), inflammation of the airways, asthma, bronchoconstriction, bronchitis, and small airways disease. The present invention also relates to the use of these compositions as a medicament and/or in the manufacture of a medicament for treating a subject suffering from a pulmonary disease, more particularly chronic obstructive pulmonary disease (COPD), inflammation of the airways, asthma, bronchoconstriction, bronchitis, and/or small airways disease. The present invention also concerns use of a composition according to the present invention in the prevention and/or treatment of said diseases and disorders. In addition, the present invention also provides methods for preventing and/or treating and/or prophylactically treating and/or alleviating by therapy said diseases and disorders.
BACKGROUND OF THE INVENTION
The airways of the human and animal body consist of a series of tubes and passages that include the throat, the larynx and the trachea. In the chest cavity the trachea divides into the right and left bronchi, or bronchial tubes, that enter the lungs. The branches of the bronchi subsequently become more narrow and form tubes, the bronchioles, that divide into even more narrow tubes, the alveolar ducts. The end of each alveolar duct forms a cluster of thinly walled sacs termed the alveoli.
Pulmonary diseases are diseases generally affecting the lungs. The airways and the lungs are subject to many disease causing and/or disease stimulating factors such as e.g. inhaled pathogens like bacteria and viruses, allergens and toxic substances such as cigarette smoke or air pollutants. Such factors generate disorders with symptoms like e.g. difficulty in breathing, chest pains, coughing, and wheezing.
Several terms have been used to describe a group of conditions now generally recognized as leading to a limitation or obstruction of the flow of air in the airways and in the lungs. Obstructive pulmonary disease (OPD) and chronic obstructive pulmonary disease (COPD) are clinical terms describing diseases characterized by an obstruction or limitation of airflow during expiration. For COPD the obstruction or limitation is persistent. The terms represent a clinical rather than a pathological diagnosis and relate to diseases such as e.g. inflammation of the airways, asthma, bronchitis, and small airways diseases. However, the nomenclature in the field of obstructive pulmonary diseases is complex and sometimes confusing in spite of many attempts to define conditions such as asthma and bronchitis.
It is widely recognized that COPD is not a disease entity, but rather a complex of conditions characterized by airflow limitation or obstruction. The limitation or obstruction may be variable over short periods of time and reversible, even though an underlying irreversible trait may persist. Unless treated, the disease is likely to progress and lead to a seriously reduced airflow limitation. This reduction is usually, but not always, persistent and typically shows a more rapid progressive deterioration with age than normal. Clinical studies of acute exacerbations of obstructive pulmonary diseases are difficult because of i) the heterogeneous nature of COPD, ii) diffuse symptoms that can vary spontaneously, and iii) difficulties in defining a clinical response both in the short term and in the long run. Also, the role of e.g. bacterial infections and the subsequent use of antibiotics in connection with pulmonary diseases is controversial, and much evidence shows that although bacterial infections have a significant role in acute exacerbation, the role of said infections in the progression of obstructive pulmonary diseases is less certain.
Accordingly, any of the above-mentioned conditions—whether transient or chronic—may result in an airflow limitation or obstruction and may therefore be potentially associated with obstructive pulmonary diseases. The conditions may, however, also be present anatomically without generating an impairment of pulmonary function that is sufficient to qualify for the definition OPD or COPD.
An obstruction of the airways is measured by FEV
1
as forced expiratory volume in the first second of expiration. Lung function measured as the FEV
1
increases into young adulthood and then it starts to decrease. In normal non-smokers, the rate of decline in FEV
1
is about 20 ml per year, i.e. about 1 liter over a 50-year period. A much more rapid decline is observed in smokers. On average, the decline is twice that of normal non-smokers. However, in about 15% of all smokers, lung function declines at a rate much more rapid than the decline observed in the average smoker. Consequently, airways diseases are strongly influenced by individual rates of decline in FEV
1
.
Asthma has traditionally been regarded as a respiratory disease of acute airway obstruction, and research as well as therapeutic attention has focused principally on the mechanisms leading to acute bronchospasm. One of the conventional therapies has consisted of bronchodilators to regulate airway smooth muscle contraction. However, current state of the art asthma therapy does have side effects, mostly due to undesirable effects from the inhalation steroids used.
A wide range of pharmaceuticals have been developed by the pharmaceutical industry and evaluated in clinical trials. Although being capable of inhibiting mast cell-mediated acute allergic bronchoconstriction, none of these pharmaceuticals are suitable for use in a prophylactical treatment or maintenance treatment of asthma. Medicaments such as &bgr;
2
agonists have been introduced in order to treat airways diseases and in particular asthma. &bgr;
2
agonists inhibit the release of histamine into the circulation of asthmatics undergoing an allergen provocation. This pharmacological property may contribute to the well-recognized ability of &bgr;
2
agonists to inhibit allergen-induced bronchoconstriction. However, while &bgr;
2
agonists are exceptional mast cell stabilizing agents, sole therapy with these agents may actually enhance hyperresponsiveness of airways to exogenous stimuli such as inhaled histamine, most likely due to a minimal effect on airway inflammation.
Widespread use of &bgr;
2
agonists have lead to a criticism based on a hypothesis involving the so-called “asthma paradox”. According to the hypothesis, &bgr;
2
agonists have undesirable effects on the normal role of mast cell degranulation as an endogenous anti-inflammatory mechanism to prevent antigens from entering the lower airways and limit the extent of the subsequent repair process.
Adlercreutz (Finnish Medical Society, Ann. Med. 29,95-120 (1997)) has reviewed the phytoestrogen classes of lignans and isoflavones and has described their influences on a range of cellular activities and metabolic events. It is stated that despite an abundant literature at this early stage of dietary phytoestrogen research, much work is needed before any recommendation as to phytoestrogen consumption can be made. However, experimental and epidemiological evidence does support the view that these compounds do not have any negative effects and that they may form a group of substances with a great potential in preventive medicine. It is emphasised that at present, no definite recommendations can be made as to the dietary amounts needed for disease prevention. No reference is made to a composition comprising a combination of soy protein, a high content of a phytoestrogen compound, and dietary fibres. Gooderham (J. Nutr. 126(8), 2000-2006 (1996)) has suggested that although soy protein supplementation to a typical Western diet may increase plasma concentrations of isoflavones, this may not necessarily be sufficient to counter disease risk factors. Increases in serum levels of isoflavones following a soy rich diet were foun
Nutri Pharma ASA
Szekeres Gabor L.
Tate Christopher R.
Winston Randall
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