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Methods and materials for treating and preventing inflammation of mucosal tissue

a technology of mucosal tissue and mucosal inflammation, which is applied in the field of methods and materials for treating and preventing can solve the problems of rhinosinusitis, the inflammation of mucosal tissue, and the serious medical problem that affects millions of people worldwide, and achieves the effects of reducing inflammation, preventing afs symptoms, and reducing the level of fungal organisms

Inactive Publication Date: 2005-06-09
MAYO FOUND FOR MEDICAL EDUCATION & RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008] 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.
[0009] 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.

Problems solved by technology

Mucositis, the inflammation of mucosal tissue, is a serious medical problem that affects millions of people worldwide.
Computed topography (CT) scans of patients with AFS have a characteristic appearance and often reveal bone erosion in adjacent structures.
Although fungal organisms seem to be the causative agent of AFS, successful treatment remains lacking.
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.
Thus, neither surgery nor steroid therapy is particularly effective or desirable as a long-term treatment for chronic rhinosinusitis conditions.
Such medical approaches can have side effects, can be costly, and may be associated with patient discomfort.
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.
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.

Method used

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  • Methods and materials for treating and preventing inflammation of mucosal tissue
  • Methods and materials for treating and preventing inflammation of mucosal tissue

Examples

Experimental program
Comparison scheme
Effect test

example 1

Collecting and Analyzing Mucus Samples

[0161] The following methods and materials were used to collect and analyze mucus from 202 patients. Prior to collecting the mucus, each patient was directed to inhale and then lower his or her chin toward their chest to minimize or prevent the flow of a collection solution out of the nasal-paranasal passageways via the normal drainage at the back of the throat. The collection solution was either a sterile saline solution or sterile water. In addition, each patient was positioned such that the flow of the collection fluid out of the nasal passageways would be minimized or prevented. Some patients received an administration of a vasoconstrictor, such as phenylephrine hydrochloride (1-2 sprays per nostril) or cocaine (topical liquid or powder; less than four mg per kg of body weight). Some patients received a spray of about three mL of a 20% solution of N-acetyl-L-cysteine. Patients receiving both were given the vasoconstrictor first and then abo...

example 2

Treating and Preventing Non-Invasive Fungus-Induced Rhinosinusitis

[0174] One hundred and thirty-two consecutive rhinosinusitis patients were entered into a study to evaluate the use of an antifungal agent to treat non-invasive fungus-induced rhinosinusitis. After diagnostic analysis, 125 of the 132 patients (95%) had the following criteria: (1) presence of observable disease within the nasal-paranasal anatomy as evidenced by a CT scan, (2) presence of allergic mucus as evidenced by histologic evaluation of a surgical specimen, and (3) presence of fungal organisms within nasal-paranasal mucus as evidenced by the ability to culture fungal organisms from a mucus sample. The 125 non-invasive fungus-induced rhinosinusitis patients were started on an antifungal treatment of about 20 mL of an amphotericin B solution per nostril, two to four times daily for at least three months. The concentration of the amphotericin B solution was about 100 mg per liter of saline or water. A 20 mL bulb wa...

example 3

Treating and Preventing Non-Invasive Fungus-Induced Rhinosinusitis in Patients without Previous Nasal Surgery

[0206] The following three non-invasive fungus-induced rhinosinusitis patients did not have a previous nasal surgery.

[0207] A 61 year old male was diagnosed with non-invasive fungus-induced rhinosinusitis and instructed to perform amphotericin B irrigations twice a day. Before starting the treatment, endoscopic evaluation revealed polyps filling her nasal cavity (endoscopic score 3) and the patient gave herself a symptom score of −1. After using the amphotericin B irrigations for fourteen months, endoscopic evaluation revealed no evidence of disease (endoscopic score 0) and the patient gave herself a symptom score of +2.

[0208] A 64 year old female was diagnosed with non-invasive fungus-induced rhinosinusitis and instructed to perform amphotericin B irrigations twice a day, which was later increased to four times a day. Before starting the treatment, endoscopic evaluation r...

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Abstract

The invention involves methods and materials for treating and preventing non-invasive fungus-induced mucositis. Specifically, the invention involves administrating an antifungal agent such that it contact mucus in an amount, at a frequency, and for a duration effective to prevent, reduce, or eliminate non-invasive fungus-induced rhinosinusitis. This invention also provides methods and materials for diagnosing non-invasive fungus-induced rhinosinusitis and culturing non-invasive fungus from a mammalian mucus sample as well as specific antifungal formulations and medical devices for treating and preventing non-invasive fungus-induced rhinosinusitis. In addition, the invention provides methods and materials for treating and preventing other non-invasive fungus-induced mucositis conditions such as chronic otitis media, chronic colitis, and Crohn's disease. Further, the invention involves methods and materials for treating and preventing chronic asthma symptoms.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from U.S. Provisional Application Ser. No. 60 / 062,709, filed Oct. 22, 1997, U.S. Provisional Application Ser. No. 60 / 063,414, filed Oct. 28, 1997, U.S. Provisional Application Ser. No. 60 / 063,418, filed Oct. 28, 1997, U.S. Provisional Application Ser. No. 60 / 083,272, filed Apr. 28, 1998 and U.S. Provisional Application Ser. No. 60 / 086,397, filed May 22, 1998.BACKGROUND [0002] 1. Technical Field [0003] 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. [0004] 2. Background Information [0005] 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 s...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07D249/08A61K9/00A61K9/06A61K9/08A61K9/10A61K9/12A61K9/14A61K31/00A61K31/085A61K31/135A61K31/137A61K31/19A61K31/20A61K31/201A61K31/27A61K31/343A61K31/4164A61K31/4174A61K31/4196A61K31/44A61K31/4418A61K31/443A61K31/496A61K31/506A61K31/513A61K31/5375A61K31/70A61K31/7042A61K31/7048A61K39/00A61K45/00A61K45/06A61P11/02A61P11/06A61P27/16A61P31/10C07D213/89C07D233/60C07D233/61C07D233/62C07D239/36C07D307/94C07D405/06C07D405/14C07H17/08C07K14/37C12N1/14
CPCA61K9/0043C12N1/14A61K31/085A61K31/137A61K31/19A61K31/20A61K31/201A61K31/27A61K31/343A61K31/4174A61K31/4196A61K31/4418A61K31/496A61K31/506A61K31/513A61K31/5375A61K31/7048A61K39/0002A61K45/06C07K14/37A61K31/00A61P1/00A61P11/00A61P11/02A61P11/06A61P27/16A61P29/00A61P31/04A61P31/10A61K31/70
Inventor PONIKAU, JENS
Owner MAYO FOUND FOR MEDICAL EDUCATION & RES
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