HealthyPhase 1NCT02264145
The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
A Phase 1 study testing Ethanolic Solution From HFA134a-MDI - low, Ethanolic Solution From HFA134a-MDI - medium and Ethanolic Solution From HFA134a-MDI - high in people with Healthy, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ethanolic Solution From HFA134a-MDI - low, Ethanolic Solution From HFA134a-MDI - medium and Ethanolic Solution From HFA134a-MDI - high
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Dec 1998
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: The Effect of Alcoholic-carrier Solutions Within-devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
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)
- Conditions
- Healthy
- Being tested
- Ethanolic Solution From HFA134a-MDI - low, Ethanolic Solution From HFA134a-MDI - medium, Ethanolic Solution From HFA134a-MDI - high, Ethanolic Solution From Respimat®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanolic Solution From HFA134a-MDI - lowDrug
Ethanolic Solution From HFA134a-MDI - mediumDrug
Ethanolic Solution From HFA134a-MDI - highDrug
Ethanolic Solution From Respimat®Drug
| Study group | Role | What they receive |
|---|---|---|
| Ethanolic Solution From HFA134a-MDI - low | Experimental | Not described Receives: Drug: Ethanolic Solution From HFA134a-MDI - low |
| Ethanolic Solution From HFA134a-MDI - medium | Experimental | Not described Receives: Drug: Ethanolic Solution From HFA134a-MDI - medium |
| Ethanolic Solution From HFA134a-MDI - high | Experimental | Not described Receives: Drug: Ethanolic Solution From HFA134a-MDI - high |
| Ethanolic Solution From Respimat® | Experimental | Not described Receives: Drug: Ethanolic Solution From Respimat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of blood alcohol level estimated from breath alcohol concentration after the four formulation inhalations
Measured: up to 15 min after inhalation
Secondary outcomes (5)
Breath alcohol concentration profile within each formulation
Measured: up to 15 min after inhalation
Maximum duration of alcohol detection exhaled air (Td) for each formulation
Measured: up to 15 min after inhalation
Highest breath alcohol concentration measured (Cmax)
Measured: up to 15 min after inhalation
Time to highest breath concentration (Tmax)
Measured: up to 15 min after inhalation
Number of patients with adverse events
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startNov 1998
- Primary completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264145
- Sponsor's protocol ID
- 260.3171
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcoholic-carrier Solutions Within-devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02264145
- Acronym / sponsor ID
- 260.3171
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanolic Solution From HFA134a-MDI - low | Drug | Ethanolic Solution From HFA134a-MDI - low |
| Ethanolic Solution From HFA134a-MDI - medium | Drug | Ethanolic Solution From HFA134a-MDI - medium |
| Ethanolic Solution From HFA134a-MDI - high | Drug | Ethanolic Solution From HFA134a-MDI - high |
| Ethanolic Solution From Respimat® | Drug | Ethanolic Solution From Respimat® |
Primary outcome
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
5 secondary outcomes
Breath alcohol concentration profile within each formulation
Time frame: up to 15 min after inhalation
Maximum duration of alcohol detection exhaled air (Td) for each formulation
Time frame: up to 15 min after inhalation
Highest breath alcohol concentration measured (Cmax)
Time frame: up to 15 min after inhalation
Time to highest breath concentration (Tmax)
Time frame: up to 15 min after inhalation
Number of patients with adverse events
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ethanolic Solution From HFA134a-MDI - low, Ethanolic Solution From HFA134a-MDI - medium and Ethanolic Solution From HFA134a-MDI - high in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.