Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-05-25
2003-04-29
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S031000, C514S282000, C514S394000, C514S462000, C514S560000
Reexamination Certificate
active
06555566
ABSTRACT:
BACKGROUND
1. Technical Field
The invention relates to methods and materials involved in the treatment and prevention of non-invasive fungus-induced inflammation of mucosal tissue as well as asthma symptoms.
2. Background Information
Mucositis, the inflammation of mucosal tissue, is a serious medical problem that affects millions of people worldwide. For example, conservative estimates indicate that between 20 to 40 million Americans suffer from chronic rhinosinusitis, an inflammation of the nasal cavity and/or paranasal sinuses.
For the most part, the cause of chronic rhinosinusitis is unknown. In a small percentage of patients, however, non-invasive fungal organisms living within mucus seem to be involved. Patients having this condition, now known as allergic fungal sinusitis (AFS), were first described in the early 1980's (Miller J W et al.,
Prod. Scot. Thor. Soc.
36:710 (1981) and Katzenstein A L A et al.,
J. Allergy Clin. Immunol.
72:89-93 (1983)). Specifically, about three to eight percent of chronic rhinosinusitis cases requiring surgery because of nasal obstruction caused by polyp formation have been classified as AFS. Briefly, AFS is diagnosed by the presence of inspissated mucus in the nasal-paranasal cavities. Typically, this mucus contains clumps or sheets of necrotic eosinophils, Charcot-Leyden crystals, and non-invasive fungal hyphae. In addition, patients with AFS typically have a history of nasal-paranasal polyposis and may have undergone multiple surgeries. Inflammation can affect all nasal-paranasal cavities, but also can be asymmetric involving only one side. Computed topography (CT) scans of patients with AFS have a characteristic appearance and often reveal bone erosion in adjacent structures. Indeed, destruction of bones adjacent to the sinuses and nasal areas ranging from 19 percent to 80 percent has been reported.
Although fungal organisms seem to be the causative agent of AFS, successful treatment remains lacking. Currently, AFS patients as well as most chronic rhinosinusitis patients receive surgical treatment with or without steroid therapy. Surgery helps clear the nasal-paranasal cavities when obstructed by polyps and steroid therapy helps control inflammatory responses that seem to be causing tissue and bone destruction. Unfortunately, patients treated with surgery alone almost always experience recurrent rhinosinusitis symptoms and additional polyp growth. In addition, prolonged use of steroids is associated with significant side effects and steroid therapy removal also leads to recurrent episodes of rhinosinusitis. For these reasons, people suffering from chronic rhinosinusitis conditions typically experience repeated cycles of intense inflammation, surgery, and steroid therapy followed by recurrent intense inflammation. Thus, neither surgery nor steroid therapy is particularly effective or desirable as a long-term treatment for chronic rhinosinusitis conditions.
SUMMARY
The present invention relates generally to methods and materials for treating and preventing non-invasive fungus-induced mucositis. The term “mucositis” as used herein means an inflammation, as opposed to an infection, of a mucus membrane. This invention is based on the discovery that the condition known as AFS can be treated successfully by using an antifungal agent in an amount, at a frequency, and for a duration effective to reduce inflammation caused by the presence of fungal organisms within nasal-paranasal mucus. In addition, this invention is based on the discovery that using an antifungal agent in an amount, at a frequency, and for a duration effective to maintain a reduced level of fungal organisms within nasal-paranasal mucus can prevent AFS symptoms. Specifically, the invention involves administering an antifungal agent to a mammal such that the antifungal agent contacts the mammal's mucus and reduces the presence of fungal organisms in mucus. In addition to being the only known method for successfully treating and preventing AFS, the use of an antifungal agent is particularly advantageous to a patient when compared to other currently available medical approaches to AFS such as surgical treatments and steroid therapies. Such medical approaches can have side effects, can be costly, and may be associated with patient discomfort.
This invention is also based on the discovery that most, if not all, chronic rhinosinusitis conditions have a fungal etiology and that most, if not all, cases of chronic rhinosinusitis can be treated by using an antifungal agent in an amount, at a frequency, and for a duration effective to reduce the presence of fungal organisms within nasal-paranasal mucus. In addition, using an antifungal agent in an amount, at a frequency, and for a duration effective to maintain a reduced level of fungal organisms within nasal-paranasal mucus can prevent chronic rhinosinusitis symptoms.
This discovery is contrary to the current understanding of chronic rhinosinusitis and has far-reaching implications within medicine. For example, numerous medical research articles report that about three to eight percent of chronic rhinosinusitis cases requiring surgery are AFS, a rhinosinusitis condition having a non-invasive fungal etiology. In fact, less than 150 cases of AFS have been reported in the literature over the past 15 years. It is noted that the lack of appreciation for the non-invasive fungal etiology of chronic rhinosinusitis conditions may have occurred since affected individuals are frequently found to have bacterial infections (i.e., invasive bacteria). Presumably, tissue damage caused by non-invasive fungus-induced inflammation results in a higher occurrence of bacterial infections in those damaged areas. Thus, overlaying bacterial infections in affected individuals could have masked the underlaying cause, fungal organisms within mucus.
For the purpose of this invention, the term “non-invasive fungus-induced rhinosinusitis” includes AFS as well as any other nasal-paranasal mucositis condition having a non-invasive fungal etiology.
Treating and preventing non-invasive fungus-induced rhinosinusitis, whether diagnosed as AFS or any other rhinosinusitis condition having a non-invasive fungal etiology, by using an antifungal agent circumvents the need for surgical treatments and steroid therapies that cause significant pain and suffering to the patient. Moreover, the use of antifungal agents to treat and prevent non-invasive fungus-induced rhinosinusitis actually directs treatment against the etiological agent (i.e., fungus), unlike surgical treatments, steroid therapies, and antibacterial treatments.
The term “chronic” as used herein refers to afflictions present for at least three months. It is to be understood that afflictions that are treated as described herein and become asymptomatic can be classified as chronic. Thus, chronic afflictions can be symptomatic or asymptomatic.
This invention is also based on another, equally significant, discovery that chronic asthma symptoms can be treated and prevented successfully by using an antifungal agent in an amount, at a frequency, and for a duration effective to reduce the presence of fungal organisms within airway mucus. It is also apparent from the present discoveries that antifungal agents can be administered directly to the lung airways for the treatment of chronic asthma. Again, these discoveries are contrary to the current understanding of chronic asthma and have far-reaching clinical implications. Taken together, these significant breakthroughs can potentially allow large populations to experience happier, healthier, and more productive daily lives.
Specifically, the invention provides methods and materials for treating and preventing a wide variety of mucoinflammatory diseases by using an antifungal agent. The use of an antifungal agent is a safe and highly effective treatment approach that involves mucoadministering an antifungal agent in an amount, at a frequency, and for a duration effective to reduce, prevent, or eliminate a non-invasive fungus-induced mucositis. The term “mucoadministra
Fish & Richardson P.C. P.A.
Mayo Foundation for Medical Education and Research
Weddington Kevin E.
LandOfFree
Methods and materials for treating and preventing... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Methods and materials for treating and preventing..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Methods and materials for treating and preventing... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3042590