Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing compound doai
Reexamination Certificate
2001-07-26
2003-01-07
Henley, Ray (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing compound doai
C514S826000
Reexamination Certificate
active
06503953
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to methods for treating atopic disorders, including asthma, eczema, sinusitis, bronchitis, and allergic rhinitis.
BACKGROUND
In the United States and other Western countries, the reported incidence of asthma is about 4-5% of the population. About half the cases develop before the age of ten and another third before the age of forty. The cost of treating asthma is enormous. Emergency room visits approximate two million a year and hospitalizations, about 500,000. Total cost of medication is estimated at one billion dollars a year, while the loss of productivity within the families of children is perhaps another billion dollars a year. The number of asthma prescriptions is thought to double per decade. In the United Kingdom, the cost of asthma treatment represented 11% of the national health budget.
The physiological hallmark of asthma is a reversible obstruction in the airways brought about by vascular congestion, thick tenacious secretions, bronchial wall edema, and smooth muscle contractions. During an attack, there is a compromise of lung function. Asthma is a chronic inflammatory disease of uncertain cause. A noticeable therapeutic change is the increased use of corticosteroids in its management.
The United Kingdom has one of the highest rates of asthma per capita of anywhere in the world. The jet stream flowing across the Atlantic keeps the British Isles wet, damp, and humid. They have an advanced “westernized” society and since dampness makes mildew grow, one sees a high incidence of asthma.
The United States, also a “western” society, has diversified weather due to its greater size. For instance, a large part of the western United States is desert. Denver and Arizona have two of the lowest areas of humidity and asthma. Asthmatics frequently move to these areas, particularly Arizona, because the extreme heat and low humidity dry dampness kill mildew and improve asthma.
In Sweden, high indoor humidity is associated with increased asthma. (See Aberg N. Asthma and Allergic rhinitis in Swedish conscripts. Clin Exp Allergy 1989;19:59-63; and Wickman M, Nordvall S L, Pershagen G. Risk factors in early childhood for sensitization to airborne allergens. Pediatr Allergy Immunol 1992;3:128-33.) Increases in asthma and allergic diseases are related to an increasingly unventilated environment. (See Aberg N, Hesselmar B, Aberg B, Eriksson B. Increase of asthma, allergic rhinitis and eczema in Swedish school children between 1979 and 1991. Clin and Experimental Allergy 1995;25:815-819.) High indoor humidity and houses damaged by dampness, owing to poor ventilation, are related to a high frequency of allergic symptoms. (See Andrae S, Axelson O, Bjorksten B, Frediksson M, Kjellman -IM. Symptoms of bronchial hyperreactvity and asthma in relation to environmental factors. Arch Dis Child 1988;63:473-8.) Environmental exposure early in life also seems important. (See Bjorksten B. Risk factors in early childhood for the development of atopic diseases. Allergy 1994;49:400-7; and Aberg N. Birth season variation in asthma and allergic rhinitis. Clin Exp Allergy 1989;19:643-8.) Dampness in homes expressed as moisture inside windowpanes, and as a noticeable dampness or mildew in the home, increased the risk of asthma, rhinitis and eczema, as well as a history of upper respiratory infections. There is a dose response relationship between the amount of moisture inside the Windows and risk. The highest risk from dampness exposure is in the first year of life.
A risk factor in allergic diseases is a parental history of allergic disease. About twice as many children have allergic disease if one parent was ever afflicted, and three times as many if both parents were afflicted, as compared with cases with no parental history (p<0.001). If parents smoked during the first year of life, it did not increase the risk for development of an allergic disease, not even asthma of the worst severity. The frequency of upper respiratory infections and dampness in the homes were additive, but not synergistic.
Some researchers suggested that indoor air quality and factors of a chemical or microbiological nature related to damp homes are important to the pathogenesis of allergic disease. (See Aberg N, Sundell J, Eriksson B, Hesselmar B, Aberg B. Prevalence of allergic diseases in school children in relation to family history, upper respiratory infections and residential characteristics. Allergy 1996;51 :232-237.) They also found that high indoor air humidity and dampness were strong risk factors underlying all allergic disease. Inhaled fungus seems able to cause further sensitization with resultant symptoms. High indoor air humidity and dampness might encourage fungus growth on skin and in the upper or lower respiratory tracts. He also found that recent repainting and repairing of a child's bedroom moderately increased risk of allergic disease. Repairing and repainting of bedroom walls are notorious for exposing underlying dampness and mildew and releasing it into the bedroom environment. Finnish workers reported evidence between, and association with, mold or mildew problems in school buildings and the presence of manifest and occult asthma in the pupils. (See Taskinen T, Meklin T, Nousiainen M, Husman, T, Nevalainen A, Korppi M. Moisture and mold problems in schools and respiratory manifestations in school children: clinical and skin test findings. Acta Paediatr 1997;86:1181-7.)
Yemaneberhan, et al., working in Ethiopia, believe that the asthma and allergy being seen in developing countries may be associated with the adoption of a “western” lifestyle. (See Yemaneberhan H, Bekele Z, Venn A, Lewis S, Parry E, Britton J. Prevalence of wheeze and asthma and relation to atopy in urban and rural Ethiopia. The Lancet 1997;350:85-90.) This group found that wheeze and asthma are especially rare in the rural subsistence areas of Ethiopia where there is a reduced prevalence of these symptoms in this environment. In Jimma, which is partly westernized, self-reported asthma emerged as a clinical problem about ten years before their studies began, which is consistent with an effect of new environmental exposures. Although they could not identify the factor leading to increases in asthma and allergy, general changes in the domestic environment are likely to be involved.
Furthermore, Esamai and Anabwani found in Kenya that the prevalence of wheezing, rhinitis, and itchy rashes were similar to previous studies in Estonia. (See Esamai F, Anabwani G M. Prevalence of asthma, allergic rhinitis and dermatitis in primary school children in Uasin Gishu district, Kenya. East Afr Med J 1996;73(7):474-478.) The prevalence of asthma and allergic diseases are increasing worldwide, and it is more so in developing countries, which rapidly raise the living standard of parts of their population.
Trepka et al. studied the epidemiology of asthma, rhinitis and atopic dermatitis in Eastern versus Western populations. They found that the rate of physician diagnosed asthma and rhinitis were higher in Western Germany, though there was a tendency for slightly less atopic dermatitis in children. They speculated that if lifestyle and environmental factors play a role in this process, then the incidence of disease should converge, as the two societies become more similar. (See Trepka M J, Heinrich J, Wichmann H E. The epidemiology of atopic diseases in Germany: an east-west comparison. Rev Environmental Health 1996;11(3): 119-31.)
Hong Kong studies suggest that genetic and/or environmental factors common to the families are more important than auto aeroallergen sensitization in the pathogenesis in asthma and allergy in “westernized” Asia. (See Lau Y L, Karlberg J, Yeung C Y. Prevalence of and factors associated with childhood asthma in Hong Kong. Acta Paediatrica 1995;84(7): 820-2.) In Istanbul, atopic family history, food allergy, eczema, frequent otitis media, and sinus attacks were found to be of significance in asthma's presence (22). When 1,500 lung experts met in Bangkok, Thailand, on No
Atopic Pty Ltd.
Christie Parker & Hale LLP
Henley Ray
Kim Vickie
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