Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02264145
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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)


Condition or disease Intervention/treatment Phase
Healthy 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® Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Alcoholic-carrier Solutions Within-devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
Study Start Date : November 1998
Actual Primary Completion Date : December 1998

Arm Intervention/treatment
Experimental: Ethanolic Solution From HFA134a-MDI - low Drug: Ethanolic Solution From HFA134a-MDI - low
Experimental: Ethanolic Solution From HFA134a-MDI - medium Drug: Ethanolic Solution From HFA134a-MDI - medium
Experimental: Ethanolic Solution From HFA134a-MDI - high Drug: Ethanolic Solution From HFA134a-MDI - high
Experimental: Ethanolic Solution From Respimat® Drug: Ethanolic Solution From Respimat®



Primary Outcome Measures :
  1. Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations [ Time Frame: up to 15 min after inhalation ]

Secondary Outcome Measures :
  1. Breath alcohol concentration profile within each formulation [ Time Frame: up to 15 min after inhalation ]
  2. Maximum duration of alcohol detection exhaled air (Td) for each formulation [ Time Frame: up to 15 min after inhalation ]
  3. Highest breath alcohol concentration measured (Cmax) [ Time Frame: up to 15 min after inhalation ]
  4. Time to highest breath concentration (Tmax) [ Time Frame: up to 15 min after inhalation ]
  5. Number of patients with adverse events [ Time Frame: up to 5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02264145     History of Changes
Other Study ID Numbers: 260.3171
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions
Norflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs