IP Library Granted Patent US 9,581,586
Granted Patent B2
US 9,581,586 · App. 14/712,280 · Granted Feb 28, 2017

Approach to asthma inhaler compliance using breath measurement of tetrafluoroethane

Inventors: Hye-Won Shin (Irvine, CA); Dan M. Cooper (Irvine, CA); Donald R. Blake (Irvine, CA)
Assignee: The Regents of the University of California
G01N33/497A61B5/082A61B5/4848G01N30/7206A61B5/097A61M15/00A61M2230/43G01N2033/4975
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Quick Facts
Patent No.
US 9,581,586
App. No.
14/712,280
Granted
Feb 28, 2017
Kind
B2
Abstract

The invention relates to measuring the effectiveness and an compliance of inhaler medication, such as for asthma treatment. In one embodiment, the invention provides a method of determining the effectiveness of an inhaler medication, comprising taking a measurement of HFA-134(a) from an exhaled breath of an individual after the individual has inhaled a medication, and determining an effective administration of the medication based on the presence of a high level of HFA-134(a).

Claims (26)

1. A method of determining the effectiveness of an inhaler medication, comprising:

taking a measurement of HFA-134(a) from an exhaled breath of an individual after the individual has inhaled a medication;

determining an effective administration of the medication based on the presence of a high level of HFA-134(a).

2. The method of claim 1 , wherein the individual is being treated for asthma.

3. The method of claim 1 , wherein the medication is a corticosteroid.

4. The method of claim 1 , wherein the medication is a short acting bronchodilator.

5. The method of claim 1 , wherein the medication is Flovent HFA or Proventil HFA.

6. The method of claim 1 , wherein the medication is a β2 agonist.

7. The method of claim 1 , wherein the measurement of HFA-134(a) is taken within 24 hours of inhaling the medication.

8. The method of claim 1 , wherein the measurement of HFA-134(a) is taken between 5 and 12 hours of inhaling the medication.

9. The method of claim 1 , wherein the measurement of HFA-134(a) is taken between 24 and 48 hours of inhaling the medication.

10. The method of claim 1 , wherein the high level of HFA-134(a) is at or above 300×10 6 pptv HFA-134(a) levels.

11. The method of claim 1 , wherein the high level of HFA-134(a) is an at least 10 6 order of magnitude increase relative to normal levels.

12. The method of claim 1 , wherein the high level of HFA-134(a) is an at least 10 3 order of magnitude increase relative to ambient levels of HFA-134(a).

13. The method of claim 1 , wherein the high level of HFA-134(a) is an at least 10 2 order of magnitude increase relative to ambient levels of HFA-134(a).

14. The method of claim 1 , wherein the high level of HFA-134(a) is between 3 to 300 ppmv from measurements taken immediately after inhaling the medication.

15. The method of claim 1 , wherein the high level of HFA-134(a) is about 260 pptv or more in exhaled breath.

16. The method of claim 15 , wherein the measurement of HFA-134(a) in exhaled breath is taken within 48 hours of inhaling the medication.

17. A device, comprising:

an analytic system that can take a measurement of HFA-134(a) from an exhaled breath of an individual after the individual has inhaled a medication,

take a measurement and quantify a corresponding ambient level of HFA-134(a), and

determine whether there has been an effective administration of the medication based on the presence of a high level of HFA-134(a) relative to the corresponding ambient level of HFA-134(a).

18. The device of claim 17 , wherein the HFA-134(a) levels are measured and quantified using a mass spectrometer detector (MSD).

19. The device of claim 17 , further comprising gas chromatography and mass spectrometry.

20. A method to determine compliance and treatment efficacy with inhalers, comprising examining hydrofluoroalkane (HFA) in the exhaled human breath as a biomarker of asthma inhaler compliance.

21. The method of claim 20 , further comprising two components: 1) analytical technique to measure breath HFA in a range of parts-per-million to parts-per-trillion (pptv) using gas chromatography and mass spectrometry and 2) multi-compartmental analysis of HFA biotransport in the human airway following inhaled doses of ICS to estimate HFA elimination pharmacokinetic parameters such as rate constants.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jul 20, 2018
From: UNIVERSITY OF CALIFORNIA SYS OFFICE/PRES
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 046597/0421 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 23, 2016
From: SHIN, HYE-WON; COOPER, DAN M.; BLAKE, DONALD R.
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 039514/0009 →
Continuity (2)
Provisional Application 61994814 · May 16, 2014
Related Publication 20150330964A1 · Nov 19, 2015