The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers

Phase 1

Completed

Interventions: Drug: Ethanolic Solution From HFA134a-MDI - low
Drug: Ethanolic Solution From HFA134a-MDI - medium
Drug: Ethanolic Solution From HFA134a-MDI - high
Drug: Ethanolic Solution From Respimat®

Brief Summary: The study objective is to determine the effect of the ethanolic solutions inhaled from the Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4 of ethanol) on the breath alcohol measurements in healthy volunteers.

Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open, randomized, four-way-cross-over design is chosen. The randomization is balanced and stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)

Recruitment & Eligibility

Inclusion Criteria

Healthy non-smoker volunteers without dental prothesis
18 to 45 years old, male or female
No clinically significant abnormal conditions at the screening visit. A clinically significant disease is defined as one, which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study or the subjects ability to participate in the study
Volunteer with gamma-glutamyl-transferase (GGT) level < 32 IU/L
Volunteer is able to sign informed consent in accordance with Good Clinical Practice and local legislation
Volunteers is able to be trained in the performance of technically satisfactory pulmonary function tests
Volunteer is able to be trained in the correct use HFA-MDI, Respimat® and Ethylometer
Affiliated to the National Social Security System

Exclusion Criteria

Subjects who are already taking other investigational drugs or who have taken part in another trial during the past month
Consumption of alcoholic beverage within 12 hours prior to observation period
Breast feeding or pregnant female or female with no medically approved contraception method (oral contraceptive, intra uterine device)
Subjects who have a known intolerance or hypersensitivity to aerosolized containing products and/or to any of the HFA-MDI or Respimat® excipient
Volunteer with history of drug abuse and/or alcoholism
Intensive exercise one week prior to the study
Major exposure to dust, smoke or pollution one week prior to the study
Subjects with an upper or lower respiratory tract infection within the previous four weeks to screening. This is to insure no reduced alcohol absorption by mucus
Current psychiatric disorders
Previous inclusion in the randomized period of this study
Subjects on concomitant medications

Arm && Interventions

Group	Intervention	Description
Ethanolic Solution From HFA134a-MDI - low	Ethanolic Solution From HFA134a-MDI - low	-
Ethanolic Solution From HFA134a-MDI - medium	Ethanolic Solution From HFA134a-MDI - medium	-
Ethanolic Solution From HFA134a-MDI - high	Ethanolic Solution From HFA134a-MDI - high	-
Ethanolic Solution From Respimat®	Ethanolic Solution From Respimat®	-

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations	up to 15 min after inhalation

Secondary Outcome Measures

Name	Time	Method
Breath alcohol concentration profile within each formulation	up to 15 min after inhalation
Maximum duration of alcohol detection exhaled air (Td) for each formulation	up to 15 min after inhalation
Highest breath alcohol concentration measured (Cmax)	up to 15 min after inhalation
Time to highest breath concentration (Tmax)	up to 15 min after inhalation
Number of patients with adverse events	up to 5 days

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