Flow and volume regulated inhalation for treatment of severe oral corticosteroid-dependent asthma
Inventors
Muellinger, Bernard • Scheuch, Gerhard • Hofmann, Thomas • Kroneberg, Philipp
Assignees
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Publication Number
US-8834848-B2
Publication Date
2014-09-16
Expiration Date
Abstract
A drug and device combination system used in a method for treatment of patients suffering from severe and oral corticosteroid-dependent asthma and other respiratory diseases requiring a treatment with orally administered steroids. The method for administration of the inhalable corticosteroid by a flow rate and volume regulated inhalation. The combination system of the inhalable corticosteroid and the device for regulating flow rate and volume of the inhalable corticosteroid and thus achieving delivery of said inhalable corticosteroid into the small airways of the lungs. The individually programmable device that assures safe and reproducible corticosteroid delivery compliant with treatment protocol.
Core Innovation
The invention provides a drug and device combination system for the treatment of a patient suffering from oral corticosteroid-dependent asthma. The combination comprises an inhalable corticosteroid formulation and an electronically controlled inhalation device adapted to administer the inhalable corticosteroid as an aerosol predominantly into the small airways of the lower lungs of the patient. The inhalation device generates the aerosol as an aerosol bolus with a mean particle size from about 1 µm to about 5 µm and administers the aerosol at a controlled flow rate preset to be from 100 ml/second to 400 ml/second, with an overpressure of 0.1 mbar to 40 mbar.
The electronically controlled inhalation device administers the aerosol in two or three phases, wherein a first phase is optional and consists of administering particle-free air to the patient. The first phase is followed by a second phase consisting of administration of the aerosol comprising the corticosteroid to the patient, and the second phase is followed by a third phase consisting of administration of particle-free air to the patient. The administration of the inhalable corticosteroid formulation results in complete or partial weaning of the patient from the orally administered corticosteroids and an increase of the FEV1-values of the patient.
A related implementation specifies an inhalable budesonide formulation and an electronically controlled jet nebulizer that administers the inhalable budesonide predominantly into the small airways of the lower lungs. In this implementation, the jet nebulizer administers the budesonide aerosol as a bolus with a mean particle size from about 1 µm to about 5 µm MMAD at a controlled flow rate about 200 ml/second, optionally using two or three phases including particle-free air phases, and the administration results in an increase of the FEV1 values of the patient.
Claims Coverage
The document provides three independent claims: one for a general drug-device combination system, one for a drug-device combination system specifically with budesonide, and one for a treatment method. Across these independent claims, the inventive features center on electronically controlled aerosol delivery of an inhalable corticosteroid predominantly to the small airways using an aerosol bolus with defined particle size and controlled preset flow rate, optional multi-phase delivery with particle-free air, application of overpressure, and the stated clinical outcomes.
Electronically controlled inhalation device delivering aerosol predominantly to small airways as a bolus
An electronically controlled inhalation device adapted to administer an inhalable corticosteroid formulation to the patient as an aerosol predominantly into the small airways of the lower lungs of the patient, generating the aerosol as an aerosol bolus.
Controlled bolus flow rate preset
The inhalation device is further adapted to generate the aerosol as a bolus with a mean particle size from about 1 µm to about 5 µm at a controlled flow rate preset to be from 100 ml/second to 400 ml/second.
Aerosol overpressure delivery
The inhalation device is further adapted to administer the aerosol with an overpressure of 0.1 mbar to 40 mbar.
Two or three phase administration with optional particle-free air
The inhalation device is further adapted to administer the aerosol in two or three phases wherein a first phase is optional and consists of administering particle-free air to the patient, wherein said first phase is followed by a second phase consisting of administration of the aerosol comprising the corticosteroid to the patient, and wherein said second phase is followed by a third phase consisting of administration of particle-free air to the patient.
Complete or partial oral corticosteroid weaning and increased FEV1
Such administration of the inhalable corticosteroid formulation results in complete or partial weaning of the patient from the orally administered corticosteroids and an increase of the FEV1-values of the patient.
Inhalable budesonide with electronically controlled jet nebulizer twice a day
An electronically controlled jet nebulizer adapted to administer an inhalable budesonide formulation to the patient twice a day as an aerosol predominantly into the small airways of the lower lungs of the patient.
Specific controlled flow rate about 200 ml/second for budesonide bolus
The electronically controlled jet nebulizer is further adapted to generate the aerosol as a bolus with a mean particle size from about 1 µm to about 5 µm MMAD at a controlled flow rate preset to be about 200 ml/second.
Two or three phase administration with particle-free air for budesonide
The electronically controlled jet nebulizer is further adapted to administer the aerosol in two or three phases wherein a first phase is optional and consists of administering particle-free air to the patient, wherein said first phase is followed by a second phase consisting of administration of the aerosol comprising budesonide to the patient, and wherein said second phase is followed by a third phase consisting of administration of particle-free air to the patient.
Overpressure from about 0.1 mbar to about 20 mbar for budesonide
The jet nebulizer is further adapted to administer the aerosol at an overpressure from about 0.1 mbar to about 20 mbar.
Increase of FEV1 values with budesonide administration
Such administration of the inhalable budesonide formulation results in an increase of the FEV1 values of the patient.
Method of treatment using electronically controlled delivery to small airways
Administering, with an electronically controlled inhalation device, an inhalable corticosteroid formulation predominantly into the small airways of the lower lungs of the patient.
Bolus aerosol with defined mean particle size and preset flow rate
The inhalation device administers the inhalable corticosteroid formulation as an aerosol bolus at a controlled flow rate preset to be from 100 ml/second to 400 ml/second, wherein the aerosol has a mean particle size from about 1 µm to about 5 µm.
Two or three phase administration with optional particle-free air (method)
The aerosol is administered in two or three phases wherein a first phase is optional and consists of administering particle-free air to the patient, wherein the first phase is followed by a second phase consisting of administration of the aerosol comprising the corticosteroid to the patient, and wherein the second phase is followed by a third phase consisting of administration of particle-free air to the patient.
Overpressure of 0.1 mbar to 40 mbar (method)
The aerosol is administered with an overpressure of 0.1 mbar to 40 mbar.
Complete or partial weaning and increased FEV1 (method outcome)
The administration of the inhalable corticosteroid formulation results in complete or partial weaning of the patient from the orally administered corticosteroids, and an increase of the FEV1-values of the patient.
Across the independent claims, the coverage focuses on electronically controlled inhalation of an inhalable corticosteroid predominantly into small airways using a bolus aerosol with defined mean particle size and controlled preset flow rate, optional two- or three-phase delivery incorporating particle-free air, and aerosol overpressure. The claimed clinical effect includes complete or partial weaning from orally administered corticosteroids and increased FEV1-values, with a budesonide-specific claim reciting increase of FEV1 values.
Stated Advantages
Complete or partial weaning of the patient from the orally administered corticosteroids.
Increase of the FEV1-values of the patient.
Documented Applications
Treatment of a patient suffering from oral corticosteroid-dependent asthma using the claimed drug and device combination system.
Method for the treatment of a patient suffering from oral corticosteroid-dependent asthma by administering an inhalable corticosteroid formulation predominantly into the small airways using an electronically controlled inhalation device.
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