# US 2014/0194503 A1 · Diagnosis and treatment methods for entry of gastrointestinal contents into respiratory tract > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0194503 A1 - Document ID: US20140194503A1 - Status: Published application - Kind: A1 - Application number: 14/204,751 - Filed: 2014-03-11 - Published: 2014-07-10 - Earliest claimed: 2010-06-17 - Assignees: The Regents of the University of California; Aradigm Corporation - Applicants: The Regents of the University of California; Aradigm Corporation - Inventors: Igor Gonda; Homer A. Boushey - Web page: https://patentgrep.com/patent/US20140194503A1 ## CPC - A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)} - A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)} - A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) - A61B 5/14507: {specially adapted for measuring characteristics of body fluids other than blood (devices for taking samples of body liquids A61B10/0045)} - A61B 5/4211: {Diagnosing or evaluating reflux} - G01N 33/6893: {related to diseases not provided for elsewhere} - A61B 5/14: {Devices for taking samples of blood (hypodermic syringes A61M5/00); Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood (measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06)} - A61B 5/150015: {Source of blood} - G01N 2800/06: Gastro-intestinal diseases - Y10T 436/142222: Hetero-O [e.g., ascorbic acid, etc.] - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A method of diagnosing in a subject for the purpose of determining if the subject's gastrointestinal contents has entered the subject's respiratory tract. The qualitative analysis can be also expanded into quantitative analysis, enabling the estimation of either the concentration, or the amount, or both, of the gastrointestinal contents that entered the respiratory tract. The invention also provides methods of treatment based on the identification of aspiration using the methods of the invention. ## Claims ### Claim 1 A method of determining the amount and concentration of gastric fluid in the respiratory fluid of a subject, comprising: orally administering to a subject a formulation comprising: a) a plurality of particles, wherein the particles comprise a biocompatible material that is not destroyed in the gastrointestinal or respiratory tracts and a detectable label; and b) an agent that is not absorbed from the gastrointestinal tract of a subject but is absorbed from the respiratory tract of the subject; allowing the formulation to remain in the subject over a period of time during which the subject would be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract; accessing respiratory fluid from the subject; analyzing the respiratory fluid to determine the concentration of the detectable label in the respiratory fluid; accessing a body fluid selected from urine, blood or a blood product; and analyzing the body fluid to determine if the fluid contains a level of the agent indicative of the amount of aspiration of gastrointestinal contents into the respiratory tract. ### Claim 2 (depends on 1) The method of claim 1, wherein the body fluid other than respiratory fluid is urine. ### Claim 3 (depends on 1) The method of claim 1, wherein the body fluid other than respiratory fluid is blood or a blood product. ### Claim 4 (depends on 1) The method of claim 1, wherein the respiratory fluid is collected prior to analyzing. ### Claim 5 (depends on 4) The method of claim 4, wherein the respiratory fluid is collected by taking a sample of fluid from the respiratory tract of the subject. ### Claim 6 (depends on 5) The method of claim 5, wherein the collecting is carried out by a method selected from the group consisting of bronchoscopy, spontaneous sputum collection and induced sputum production. ### Claim 7 (depends on 1) The method of claim 1, wherein the biocompatible material of the particles comprises carnauba wax and the formulation comprises an aqueous carrier. ### Claim 8 (depends on 1) The method of claim 1, wherein the detectable label of the particles is selected from the group consisting of a fluorescent label, a radioactive label, a magnetic label and a UV label. ### Claim 9 (depends on 1) The method of claim 1, wherein the particles comprise a detectable label encapsulated in a material which is not degraded in the respiratory and gastrointestinal tracts. ### Claim 10 (depends on 9) The method of claim 9, wherein the detectable label is encapsulated in carnauba wax. ### Claim 11 (depends on 9) The method of claim 9, wherein the detectable label of the particles is fluorescein. ### Claim 12 (depends on 1) The method of claim 1, wherein the concentration of the detectable label in the respiratory fluid is determined as a number of labels per unit volume of respiratory fluid obtained from the subject. ### Claim 13 (depends on 1) The method of claim 1, wherein the administered agent is selected from the group consisting of cromolyn salts, cromolynic acid, nedocromil, nedocromil salts and muscarinic acid receptor antagonists. ### Claim 14 (depends on 1) The method of claim 1, wherein the administered agent is a cromolyn salt. ### Claim 15 (depends on 1) The method of claim 1, further comprising: determining that the amount and concentration of aspiration of gastrointestinal contents into the respiratory tract is indicative of aspiration of gastrointestinal contents into the respiratory tract, and providing an intervention to the subject to reduce or prevent such aspirations. ### Claim 16 (depends on 15) The method of claim 15, wherein the intervention is a medical intervention. ### Claim 17 (depends on 1) The method of claim 1, further comprising: administering a control formulation comprising the same particles found in the diagnostic formulation to the subject during a period of time when the subject would not be expected to aspirate the formulation from the gastrointestinal tract into the respiratory tract; accessing respiratory fluid from the subject following the administration of the control dose; analyzing the respiratory fluid to determine the concentration of label in the respiratory fluid; and determining that the concentration of label following administration of the diagnostic formulation is indicative of an aspiration of gastrointestinal fluid into the respiratory tract requiring intervention by comparing it to the concentration of label following administration of the control formulation. ### Claim 18 (depends on 1) The method of claim 1, further comprising: administering a control formulation comprising the same agent as found in the diagnostic formulation to the subject at an occasion different to that when the orally administered diagnostic formulation is administered; accessing a body fluid from the subject following the administration of the control formulation; analyzing the body fluid to determine if the fluid contains the agent; and determining that the level of agent detected following administration of the diagnostic formulation is indicative of a disease associated with aspiration of gastrointestinal contents into the respiratory tract by comparison to the level of agent detected following administration of the control formulation. ### Claim 19 (depends on 18) The method of claim 18, wherein the control formulation is administered orally. ### Claim 20 (depends on 18) The method of claim 18, wherein the control formulation is administered by inhalation.