HealthyNCT00990275
Alcohol Exposure and Airway Hyperresponsiveness
A study testing ethanol in people with Healthy, run by University of Nebraska at 1 site in United States.
Trial summary
Alcohol has consequences including increased risk for upper respiratory tract infections, pneumonia, acute respiratory distress syndrome (ARDS), and alcohol-induced asthma. The investigators have established that airways are specifically impacted by alcohol exposure because the airways are heavily exposed to the vapor… Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2009to 16 Jan 2013
- Phase
- Interventional
- 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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- must be of legal drinking age in the state of Nebraska (≥ 21)
- be between the ages of 21-65
- be non-smokers
- be able to dedicate 3-4 hours on two consecutive days (including waiting at least 2 hours after the alcohol ingestion)
- able to provide informed consent
Who cannot join
- female
- inability to give informed consent
- any history of lung or allergic disease
- any alcohol intake for the week prior to the experiment
- self-identified history of chronic heavy drinking or alcoholism or psychiatric disorder
- If an otherwise qualifying participant has previously undocumented or unidentified asthma as indicated by the baseline methacholine challenge, that subject will be excluded from the remainder of the study and replaced by another subject
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Alcohol has consequences including increased risk for upper respiratory tract infections, pneumonia, acute respiratory distress syndrome (ARDS), and alcohol-induced asthma. The investigators have established that airways are specifically impacted by alcohol exposure because the airways are heavily exposed to the vapor phase of alcohol during drinking. These preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model leading to the hypothesis that alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
Read the detailed description
Alcohol has well-established consequences in the lung including increased risk for upper respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There have even been a few reports of alcohol-induced asthma. Data from the investigators' laboratory have established that the airways are specifically impacted by alcohol exposure. Because the airways are heavily exposed to the vapor phase of alcohol during drinking and airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial motor function would be altered in mice fed alcohol. The investigators' preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize that:
Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
- Conditions
- Healthy
- Being tested
- ethanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanolOther
subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Post-alcohol change in airway hyperresponsiveness. | Experimental | Participants will ingest 3 ounces of vodka mixed with fruit juice within 30 min. Then provocative concentration causing a 20% fall in forced expiratory volume in 1 s (PC20FEV1) will be measured. A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness. Receives: Other: ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway hyperresponsiveness.
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study start1 Oct 2009
- Primary completion16 Jan 2013
- Study completion16 Jan 2013
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 University of NebraskaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Joseph H Sisson, MD, Study director, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990275
- Sponsor's protocol ID
- 0268-07-FB
- Other IDs
- 1F32AA017024-01
- Status last verified
- Aug 2023
- First submitted
- 2 Oct 2009
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Exposure and Airway Hyperresponsiveness
- ClinicalTrials.gov ID
- NCT00990275
- Acronym / sponsor ID
- 0268-07-FB
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 16 Jan 2013 (actual)
- Study completion
- 16 Jan 2013 (actual)
- First posted
- 6 Oct 2009 (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.
Alcohol has consequences including increased risk for upper respiratory tract infections, pneumonia, acute respiratory distress syndrome (ARDS), and alcohol-induced asthma. The investigators have established that airways are specifically impacted by alcohol exposure because the airways are heavily exposed to the vapor phase of alcohol during drinking. These preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model leading to the hypothesis that alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
Detailed description
Alcohol has well-established consequences in the lung including increased risk for upper respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There have even been a few reports of alcohol-induced asthma. Data from the investigators' laboratory have established that the airways are specifically impacted by alcohol exposure. Because the airways are heavily exposed to the vapor phase of alcohol during drinking and airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial motor function would be altered in mice fed alcohol. The investigators' preliminary studies demonstrate that brief alcohol administration significantly attenuates airway hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize that:
Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-alcohol change in airway hyperresponsiveness. | Experimental | Other: ethanolParticipants will ingest 3 ounces of vodka mixed with fruit juice within 30 min. Then provocative concentration causing a 20% fall in forced expiratory volume in 1 s (PC20FEV1) will be measured. A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male
- must be of legal drinking age in the state of Nebraska (≥ 21)
- be between the ages of 21-65
- be non-smokers
- be able to dedicate 3-4 hours on two consecutive days (including waiting at least 2 hours after the alcohol ingestion)
Key exclusion criteria (6 listed)
- female
- inability to give informed consent
- any history of lung or allergic disease
- any alcohol intake for the week prior to the experiment
- self-identified history of chronic heavy drinking or alcoholism or psychiatric disorder
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 |
|---|---|---|
| ethanolsubjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min. | Other | Post-alcohol change in airway hyperresponsiveness. |
Primary outcome
Change in airway hyperresponsiveness.
Time frame: 2 hours
A one-half concentration difference in the PC20FEV1 will be considered a statistically significant change in airway hyperresponsiveness.
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 6 Sep 2023.
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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.
Joseph H Sisson, MD study director
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol in people with Healthy, run by University of Nebraska at 1 site in United States.
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 6 inclusion and 6 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change in airway hyperresponsiveness. (time frame: 2 hours). 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 6 Sep 2023.