# US 2014/0194502 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 2014/0194502 A1 - Document ID: US20140194502A1 - Status: Published application - Kind: A1 - Application number: 14/204,719 - Filed: 2014-03-11 - Published: 2014-07-10 - Earliest claimed: 2010-06-17 - Assignees: Aradigm Corporation - Applicants: Aradigm Corporation - Inventors: Igor Gonda - Web page: https://patentgrep.com/patent/US20140194502A1 ## CPC - G01N 33/94: involving narcotics {or drugs or pharmaceuticals, neurotransmitters or associated receptors} - 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} - A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)} - G01N 33/58: involving labelled substances (G01N33/53 takes precedence) - G01N 33/6893: {related to diseases not provided for elsewhere} - A61B 5/150015: {Source of blood} - G01N 2800/06: Gastro-intestinal diseases - Y10T 436/142222: Hetero-O [e.g., ascorbic acid, etc.] - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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) - 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 treating a subject suffering from entry of gastrointestinal contents into the respiratory tract, comprising: orally administering to a subject a diagnostic formulation comprising an agent that is not absorbed from the gastrointestinal tract of a mammal but is absorbed from the respiratory tract of a mammal; allowing the diagnostic 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 a body fluid from the subject, wherein the body fluid is urine, blood or a blood product; analyzing the body fluid to detect the level of the agent in the body fluid; determining that the fluid contains a level of the agent indicative of aspiration of gastrointestinal contents into the respiratory tract, and providing an intervention to prevent or reduce such aspirations in the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the body fluid is collected prior to analyzing the body fluid. ### Claim 3 (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 4 (depends on 1) The method of claim 1, wherein the administered agent is a cromolyn salt. ### Claim 5 (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 6 (depends on 5) The method of claim 5, wherein the control formulation is administered orally. ### Claim 7 (depends on 5) The method of claim 5, wherein the control formulation is administered by inhalation. ### Claim 8 (depends on 5) The method of any of claim 5, wherein the body fluid is collected following the administration of the control formulation and prior to analyzing the body fluid. ### Claim 9 (depends on 5) The method of claim 5, wherein the control formulation is administered during a period of time when the subject is not expected to experience aspiration of gastrointestinal contents into the respiratory tract. ### Claim 10 (depends on 1) The method of claim 1, further comprising: detecting a level of the agent indicative of aspiration of gastrointestinal contents into the respiratory tract based on the level of the agent observed following administration of the control formulation; and administering to the subject a medical treatment to reduce or prevent such aspiration. ### Claim 11 A method of treating a subject suffering from entry of gastrointestinal contents into the respiratory tract, comprising: orally administering to a subject a diagnostic formulation comprising a cromolyn salt; allowing the diagnostic 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 a body fluid from the subject, wherein the body fluid is urine, blood or a blood product; analyzing the body fluid to detect the level of cromolyn salt in the body fluid; determining that the fluid contains a level of cromolyn salt indicative of aspiration of gastrointestinal contents into the respiratory tract, and providing an intervention to prevent or reduce such aspirations in the subject. ### Claim 12 (depends on 11) The method of claim 11, wherein the body fluid is collected prior to analyzing the body fluid. ### Claim 13 (depends on 11) The method of claim 11, further comprising: administering a control formulation comprising the cromolyn salt 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 cromolyn salt; and determining that the level of cromolyn salt 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 cromolyn salt detected following administration of the control formulation. ### Claim 14 (depends on 13) The method of claim 13, wherein the control formulation is administered orally. ### Claim 15 (depends on 13) The method of claim 13, wherein the control formulation is administered by inhalation. ### Claim 16 (depends on 13) The method of claim 13, wherein the body fluid is collected following the administration of the control formulation and prior to analyzing the body fluid. ### Claim 17 (depends on 13) The method of claim 13, wherein the control formulation is administered during a period of time when the subject is not expected to experience aspiration of gastrointestinal contents into the respiratory tract. ### Claim 18 (depends on 11) The method of claim 11, further comprising: detecting a level of the agent indicative of aspiration of gastrointestinal contents into the respiratory tract based on the level of the agent observed following administration of the control formulation; and administering to the subject a medical treatment to reduce or prevent such aspiration. ### Claim 19 A dipstick device for the detection of an agent indicative of aspiration of gastrointestinal contents into the respiratory tract of a subject, comprising: a substrate comprised of paper and a first reagent that reacts with the agent; and a second reagent that enables the reaction of the first reagent to form a dye with the agent that is of a different color than the color either the first or the second reagent. ### Claim 20 (depends on 19) The method of claim 19, wherein the agent is selected from the group consisting of cromolyn salts, cromolynic acid, nedocromil, nedocromil salts and muscarinic acid receptor antagonists. ### Claim 21 (depends on 19) The method of claim 19, wherein the agent is a cromolyn salt. ### Claim 22 A dipstick device for the detection of an agent indicative of aspiration of gastrointestinal contents into the respiratory tract of a subject, comprising, comprising: a substrate comprised of paper and a reagent that reacts with the agent to form a compound with a visually detectable color. ### Claim 23 (depends on 22) The method of claim 22, wherein the agent is selected from the group consisting of cromolyn salts, cromolynic acid, nedocromil, nedocromil salts and muscarinic acid receptor antagonists. ### Claim 24 (depends on 22) The method of claim 22, wherein the agent is a cromolyn salt. ### Claim 25 A dipstick device for the detection of an agent indicative of aspiration of gastrointestinal contents into the respiratory tract of a subject, comprising: a substrate comprised of paper and a first reagent that reacts with the agent; and a second reagent that enables the reaction of the first reagent to form a compound with a visually detectable color. ### Claim 26 (depends on 25) The method of claim 25, wherein the agent is selected from the group consisting of cromolyn salts, cromolynic acid, nedocromil, nedocromil salts and muscarinic acid receptor antagonists. ### Claim 27 (depends on 25) The method of claim 25, wherein the agent is a cromolyn salt.