Legionnaires' DiseaseNCT03321786
Legionnaires' Effect on Smell
An observational study of Legionnaires' Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to determine whether survivors of Legionnaires' disease suffer smell loss. A quantitative olfactory test will be performed by the participants. Such testing will require approximately 20-30 minutes of the participant's time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Legionnaires' Disease
- What is being tested?
- The University of Pennsylvania Smell Identification Test (UPSIT)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 15 Jun 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The subjects to be tested in this study represent two different populations. The first is a group of who have survived Legionnaires' disease. The second group will be healthy men and women over the age of 18 years.
Who may be able to join
- Persons of generally good health, as obtained from a screening questionnaire who are 18 years of age and older
- Both men and women of all ethnic backgrounds will be accepted.
Who cannot join
- Age less than 18
- Pregnant Women
- Persons who mental competence is limited, such as those with dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Legionella Pneumonia's Effect on Olfactory Function
The goal of this study is to determine whether survivors of Legionnaires' disease suffer smell loss. A quantitative olfactory test will be performed by the participants. Such testing will require approximately 20-30 minutes of the participant's time. The participants will take the University of Pennsylvania Smell Identification Test (UPSIT), a scratch-and-sniff test to assess their ability to identify odors in a forced- choice format. Volunteers will also complete a questionnaire asking personal history, demographic questions, and medical history.
- Conditions
- Legionnaires' Disease
- Being tested
- The University of Pennsylvania Smell Identification Test (UPSIT)
- Medical subject headings
- Legionnaires' Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The University of Pennsylvania Smell Identification Test (UPSIT)Other
This standardized test, the most widely used olfactory test in the world, is derived from basic psychological test measurement theory and focuses on the comparative ability of subjects to identify odorants at the suprathreshold level. The UPSIT consists of four envelope-sized booklets, each containing ten "scratch and sniff" odorants embedded in 10- 50-µm polymer microcapsules positioned on brown strips at the bottom of the pages of the booklets.
| Study group | Role | What they receive |
|---|---|---|
| Legionnaires' Disease Volunteers | Volunteers who have been diagnosed/survivors of Legionnaire's Disease Receives: Other: The University of Pennsylvania Smell Identification Test (UPSIT) | |
| Healthy Volunteers | Volunteers who are healthy. Receives: Other: The University of Pennsylvania Smell Identification Test (UPSIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the University of Pennsylvania Smell Identification Test
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test.
The total number of correct responses will then be compared to standard norms of correct responses based on demographic information such as age and sex. Comparing the scores to the standard norms collected will indicate whether a volunteer is normosmic, hyposmic, or anosmic.
Measured: 20-30 Minutes
Secondary outcomes (1)
Questionnaire Responses
These are various demographic and medical history questions regarding exposure to Legionella Pneumonia and current experiences post diagnosis and treatment.
Measured: 20-30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start6 Sep 2017
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legionnaires' DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Doty, University of Pennsylvania
- Investigators
- Richard L Doty, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321786
- Sponsor's protocol ID
- 827730
- Status last verified
- Jul 2024
- First submitted
- 23 Oct 2017
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legionella Pneumonia's Effect on Olfactory Function
- ClinicalTrials.gov ID
- NCT03321786
- Acronym / sponsor ID
- 827730
- Conditions
- Legionnaires' Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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 goal of this study is to determine whether survivors of Legionnaires' disease suffer smell loss. A quantitative olfactory test will be performed by the participants. Such testing will require approximately 20-30 minutes of the participant's time. The participants will take the University of Pennsylvania Smell Identification Test (UPSIT), a scratch-and-sniff test to assess their ability to identify odors in a forced- choice format. Volunteers will also complete a questionnaire asking personal history, demographic questions, and medical history.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Legionnaires' Disease Volunteers | – | Other: The University of Pennsylvania Smell Identification Test (UPSIT)Volunteers who have been diagnosed/survivors of Legionnaire's Disease |
| Healthy Volunteers | – | Other: The University of Pennsylvania Smell Identification Test (UPSIT)Volunteers who are healthy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects to be tested in this study represent two different populations. The first is a group of who have survived Legionnaires' disease. The second group will be healthy men and women over the age of 18 years.
Key inclusion criteria (2 listed)
- Persons of generally good health, as obtained from a screening questionnaire who are 18 years of age and older
- Both men and women of all ethnic backgrounds will be accepted.
Key exclusion criteria (3 listed)
- Age less than 18
- Pregnant Women
- Persons who mental competence is limited, such as those with dementia
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 |
|---|---|---|
| The University of Pennsylvania Smell Identification Test (UPSIT)This standardized test, the most widely used olfactory test in the world, is derived from basic psychological test measurement theory and focuses on the comparative ability of subjects to identify odorants at the suprathreshold level. The UPSIT consists of four envelope-sized booklets, each containing ten "scratch and sniff" odorants embedded in 10- 50-µm polymer microcapsules positioned on brown strips at the bottom of the pages of the booklets. | Other | Healthy Volunteers, Legionnaires' Disease Volunteers |
Primary outcome
Score on the University of Pennsylvania Smell Identification Test
Time frame: 20-30 Minutes
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test. The total number of correct responses will then be compared to standard norms of correct responses based on demographic information such as age and sex. Comparing the scores to the standard norms collected will indicate whether a volunteer is normosmic, hyposmic, or anosmic.
1 secondary outcome
Questionnaire Responses
Time frame: 20-30 Minutes
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 24 Jul 2024.
Related trials for Legionnaires' Disease
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Respiratory Infections, COVID-19
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.
Richard L Doty, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Legionnaires' Disease, run by University of Pennsylvania 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 2 inclusion and 3 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 24 Jul 2024. 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?
Score on the University of Pennsylvania Smell Identification Test (time frame: 20-30 Minutes). 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 24 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.