AsthmaNCT00839748
The Ohio State University Asthma Registry
An observational study of Asthma, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to collect information in order to identify people who have asthma and who may be good candidates to participate in one of the future asthma studies to be conducted at The Ohio State University Asthma Clinical Research Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, community sample
Who may be able to join
- asthma
- must be able to provide medical history
Who cannot join
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to collect information in order to identify people who have asthma and who may be good candidates to participate in one of the future asthma studies to be conducted at The Ohio State University Asthma Clinical Research Center.
Read the detailed description
Patients from The Ohio State University Division of Pulmonary and Critical Care Medicine will be sent a letter explaining the registry and asking about their interest in participating in this registry. The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity. Information about the registry will be shared with the community by newspaper ads, Internet postings, word of mouth, flyers, and other pulmonologists in central Ohio. Those potential registrants may choose to make an appointment to complete lung function tests at the Asthma Clinical Research Center.
The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity.
Each participant will be asked to provide appropriate (general medical history, asthma history, current medications, past asthma medications, demographic information, weight height, smoking history, allergies, and prior surgeries. Participants will be asked to complete an Asthma Control Questionnaire, which will be scored to determine how well their asthma is controlled. All consented registrants will be given the opportunity to visit The Ohio State University Asthma Clinical Research Center where an extensive lung function test (spirometry) will be provided. At the Asthma Clinical Research Center each registrant will perform at least three lung function efforts, then given two puffs of albuterol (a fast acting medication that opens airways). After a standard waiting period that meets the standards of the American Thoracic Society, a second set of lung function test will be done. The results of the second set of tests will reflect any reversibility in lung function levels, and will serve as an indicator that treatment may improve lung function. All participants will be given copies of all lung function tests, and the results of the test will be explained to them. All study procedures are provided without cost to the registrant.
- Conditions
- Asthma
- Keywords
- asthma, registry for future asthmatic studies, questionnaires, lung function tests
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asthmatics | asthmatics registry for those interested in future asthma studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
an asthmatic agrees to have their name and information put in the registry will help study staff determine the most likely candidates for each study
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJan 2017
- Primary completionOct 2021
- Study completionOct 2021
Why it stopped: personnel redeployment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Parsons, Ohio State University
- Investigators
- Jonathan Parsons, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839748
- Sponsor's protocol ID
- 2003H0221
- Status last verified
- Oct 2021
- First submitted
- 6 Feb 2009
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ohio State University Asthma Registry
- ClinicalTrials.gov ID
- NCT00839748
- Acronym / sponsor ID
- 2003H0221
- Conditions
- Asthma
- Keywords
- asthma, registry for future asthmatic studies, questionnaires, lung function tests
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: personnel redeployment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 9 Feb 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.
The purpose of this study is to collect information in order to identify people who have asthma and who may be good candidates to participate in one of the future asthma studies to be conducted at The Ohio State University Asthma Clinical Research Center.
Detailed description
Patients from The Ohio State University Division of Pulmonary and Critical Care Medicine will be sent a letter explaining the registry and asking about their interest in participating in this registry. The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity. Information about the registry will be shared with the community by newspaper ads, Internet postings, word of mouth, flyers, and other pulmonologists in central Ohio. Those potential registrants may choose to make an appointment to complete lung function tests at the Asthma Clinical Research Center.
The registry and all procedures related to their inclusion will be explained, opportunity to ask questions will be given and a consent document signed prior to any registry activity.
Each participant will be asked to provide appropriate (general medical history, asthma history, current medications, past asthma medications, demographic information, weight height, smoking history, allergies, and prior surgeries. Participants will be asked to complete an Asthma Control Questionnaire, which will be scored to determine how well their asthma is controlled. All consented registrants will be given the opportunity to visit The Ohio State University Asthma Clinical Research Center where an extensive lung function test (spirometry) will be provided. At the Asthma Clinical Research Center each registrant will perform at least three lung function efforts, then given two puffs of albuterol (a fast acting medication that opens airways). After a standard waiting period that meets the standards of the American Thoracic Society, a second set of lung function test will be done. The results of the second set of tests will reflect any reversibility in lung function levels, and will serve as an indicator that treatment may improve lung function. All participants will be given copies of all lung function tests, and the results of the test will be explained to them. All study procedures are provided without cost to the registrant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthmatics | – | –asthmatics registry for those interested in future asthma studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, community sample
Key inclusion criteria (2 listed)
- asthma
- must be able to provide medical history
Key exclusion criteria (1 listed)
- unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
an asthmatic agrees to have their name and information put in the registry will help study staff determine the most likely candidates for each study
Time frame: end of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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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.
Jonathan Parsons, MD principal investigator
Ohio State University
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 Asthma, run by Ohio State University 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 1 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: withdrawn, as of the sponsor's last update on 1 Nov 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
an asthmatic agrees to have their name and information put in the registry will help study staff determine the most likely candidates for each study (time frame: end of study). 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 1 Nov 2021.