The Effect of Alcoholic-carrier Solutions Within Devices... | NCT02264145

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

NCT02264145

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Ethanolic Solution From HFA134a-MDI - low
Ethanolic Solution From HFA134a-MDI - medium
Ethanolic Solution From HFA134a-MDI - high
Ethanolic Solution From Respimat®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1998

Primary Completion Date

Dec 1998Actual

Completion Date

Not provided

First Submitted Date

Oct 14, 2014

First Submission Date that Met QC Criteria

Oct 14, 2014

First Posted Date

Oct 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Ethanolic Solution From HFA134a-MDI - low	Experimental	Drug: Ethanolic Solution From HFA134a-MDI - low
Ethanolic Solution From HFA134a-MDI - medium	Experimental	Drug: Ethanolic Solution From HFA134a-MDI - medium
Ethanolic Solution From HFA134a-MDI - high	Experimental	Drug: Ethanolic Solution From HFA134a-MDI - high
Ethanolic Solution From Respimat®	Experimental	Drug: Ethanolic Solution From Respimat®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ethanolic Solution From HFA134a-MDI - low	Drug		Ethanolic Solution From HFA134a-MDI - low
Ethanolic Solution From HFA134a-MDI - medium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided