Methods and devices for treating lung dysfunction

Details Methods and devices for treating lung dysfunction Methods and devices for treating lung dysfunction

2002-05-14

2004-03-09

Hartley, Michael G. (Department: 1616)

Drug, bio-affecting and body treating compositions

Effervescent or pressurized fluid containing

Organic pressurized fluid

C043S094000, C514S851000, C514S021800, C514S931000, C128S200140

Reexamination Certificate

active

06702998

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to methods and devices for treating various medical conditions, e.g., lung dysfunction. Some of the conditions are related to cystic fibrosis, and others may be more widely applicable.
BACKGROUND OF THE INVENTION
Cystic fibrosis (CF) is the most common life-shortening genetic disease in the white population. It occurs in the USA in about {fraction (1/3,300)} white births, {fraction (1/15,300)} black births, and {fraction (1/32,000)} Asian-American births; 30% of patients are adults. See, e.g., Berkow (ed.)
The Merck Manual of Diagnosis and Therapy
Merck & Co., Rahway, N. J.; Thorn, et al.
Harrison's Principles of Internal Medicine
McGraw-Hill, N.Y.; and Weatherall, et al. (eds.)
Oxford Textbook of Medicine
Oxford University Press, Oxford; the Cystic Fibrosis Foundation website (www.cff.org); Davis (ed. 1993)
Cystic Fibrosis
Marcel Dekker, ISBN: 082478815X; Dodge (ed. 1996)
Cystic Fibrosis: Current Topics
Wiley & Son, ISBN: 0471963534; Bauernfeind, et al. (eds. 1996)
Cystic Fibrosis Pulmonary Infections: Lessons from Around the World
(Respiratory Pharmacology and Pharmacotherapy) Springer Verlag, ISBN: 081765027X; Orenstein and Stern (eds. 1998)
Treatment of the Hospitalized Cystic Fibrosis Patient
Marcel Dekker, ISBN: 0824795008; Hodson, et al. (eds. 2000)
Cystic Fibrosis
Oxford Univ. Press, ISBN: 0340742089; and Yankaskas and Knowles (eds. 1999)
Cystic Fibrosis in Adults
Lippincott Pubs, ISBN: 0781710111. See also Conese and Assael (2001) “Bacterial infections and inflammation in the lungs of cystic fibrosis patients”
Ped. Infect. Dis. J
. 20:207-213; Moss (2001) “New approaches to cystic fibrosis”
Hosp. Pract
. (Off. Ed.) 36:25-27, 31-32, 35-37; Robinson (2001) “Cystic fibrosis”
Thorax
56:237-241; Ratjen (2001) “Changes in strategies for optimal antibacterial therapy in cystic fibrosis”
Int. J. Antimicrob. Agents
17:93-96; Hodson (2000) “Treatment of cystic fibrosis in the adult”
Respiration
67:595-607; Doring, et al. (2000) “Antibiotic therapy against
Pseudomonas aeruginosa
in cystic fibrosis: a European consensus”
Eur. Respir. J
. 16:749-767; Beringer and Appleman (2000) “Unusual respiratory bacterial flora in cystic fibrosis: microbiologic and clinical features”
Curr. Opin. Pulm. Med
. 6:545-550; Larson and Cohen (2000) “Cystic fibrosis revisited”
Mol. Genet. Metab
. 71:470-477; Nasr (2000) “Cystic fibrosis in adolescents and young adults”
Adolesc. Med.
11:589-603; Rahman and MacNee (2000) “Oxidative stress and regulation of glutathione in lung inflammation”
Eur. Respir. J
. 16:534-554; and Koch and Hoiby (2000) “Diagnosis and treatment of cystic fibrosis”
Respiration
67:239-247.
CF is typically carried as an autosomal recessive trait by about 3% of the white population. The most common gene responsible has been localized to 250,000 base pairs of genomic DNA on chromosome 7q (the long arm). This encodes a membrane-associated protein called the cystic fibrosis transmembrane regulator (CFTR). The most common gene mutation, F508, leads to absence of a phenylalanine residue at position 508 on the CFTR protein and is found on about 70% of CF alleles; >600 less common mutations account for the remaining 30%. Although the exact function of CFTR is unknown, it appears to be part of a cAMP-regulated Cl
−
channel and appears to regulate Cl
−
and Na
+
transport across epithelial membranes. Heterozygotes may show subtle abnormalities of epithelial transport but are clinically unaffected.
Fifty percent of patients present with pulmonary manifestations, usually chronic cough and wheezing associated with recurrent or chronic pulmonary infections. Cough is the most troublesome complaint, often accompanied by sputum, gagging, vomiting, and disturbed sleep. Intercostal retractions, use of accessory muscles of respiration, a barrel-chest deformity, digital clubbing, and cyanosis occur with disease progression. Upper respiratory tract involvement includes nasal polyposis and chronic or recurrent sinusitis. Adolescents may have retarded growth, delayed onset of puberty, and a declining tolerance for exercise. Pulmonary complications in adolescents and adults include pneumothorax, hemoptysis, and right heart failure secondary to pulmonary hypertension.
Cystic fibrosis still presents major health problems to afflicted individuals. It is a highly debilitating condition, and affects significant numbers of patients. As such, there is great need for new and more effective treatments. The present invention addresses these and other problems.
SUMMARY OF THE INVENTION
The present invention provides methods method of treating a respiratory tract infection in a primate suffering from cystic fibrosis or other respiratory tract condition, comprising administering to the primate an effective amount of aerosolized thiocyanate or halides. In certain embodiments, the treating is after symptoms of bacterial infection have been detected or perhaps for viral infections instead or for bacterial infections that follow viral infections of the respiratory tract. Typically, the lung infection is:
Staphylococus aureus; Pseudomonas aeruginosa
; or
Burkholeria cepacia
. The method may be used in combination, e.g., with a peroxidase; H
2
O
2
; and/or another treatment for a lung infection or cystic fibrosis. Such other treatments may be, e.g., an antibiotic; an antiviral; an enzyme; or a manipulation.
In another embodiment, the invention provides methods of treating a respiratory infection, e.g., lung, in a mammal, comprising administering to the mammal an effective amount of thiocyanate or other halides, e.g., I
−
, Br
−
, etc. Often, the administering is: by aerosol inhalation of the thiocyanate; or in combination with: an antibiotic; an antiviral; an enzyme; H
2
O
2
; or a medical manipulation. The lung infection is likely to be:
Staphylococus aureus; Pseudomonas aeruginosa
; or
Burkholeria cepacia
. In various embodiments, the effective amount of thiocyanate is between about 5 &mgr;M and 4 mM in the lung fluid; or the administering occurs between one administration in a week to hourly.
Another embodiment includes methods of treating a lung condition in a primate or rodent suffering from symptoms of cystic fibrosis, the method comprising administering to the lung of the creature an effective amount of thiocyanate. Typically, the administering is by inhalation of aerosolized thiocyanate; the creature is a mouse or rat; the creature suffers from a lung infection; or the treating further includes administration of a peroxidase or H
2
O
2
.
Yet another embodiment encompasses an inhaler comprising: thiocyanate, or a peroxidase and labeled, e.g., instructions, for administration to an individual with cystic fibrosis. The inhaler may further comprise an antibiotic or antiviral therapeutic. The individual may have a lung infection.
DETAILED DESCRIPTION OF THE INVENTION
Outline
I. Cystic Fibrosis
II. Current CF Treatments
III. The Lactoperoxidase (LPO) System
IV. Therapeutic Applications
In accordance with the objects outlined above, the present invention provides novel methods for treating or preventing signs or symptoms of respiratory dysfunction, particularly infections resulting from compromised airway functions related to resistance to infectious agents which enter the body through the airway mucosa. Devices are provided which are useful in addressing these problems.
Descriptions of lung immunity is applicable to other parts of the respiratory tract. Since the mechanisms described herein are common to airways in genera, the applications described would also apply to other airway mucosal surfaces.
I. Cystic Fibrosis
Cystic fibrosis is the most common genetic disorder among Caucasians. The disease is characterized by chronic respiratory infection that begins early in life with
Staphylococcus aureus
and
Haemophilus influenzae
infections and later colonization with mucoid strains of
Pseudomonas aeruginosa
. Chronic respiratory infection results in progressive loss of lung function and greatly dimi

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