The Ohio State University Asthma Registry
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| First Received Date ICMJE | February 6, 2009 | ||||||||
| Last Updated Date | May 13, 2013 | ||||||||
| Start Date ICMJE | February 2004 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00839748 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Ohio State University Asthma Registry | ||||||||
| Official Title ICMJE | The Ohio State University Asthma Registry | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | primary care clinic, community sample |
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| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | asthmatics
asthmatics registry for those interested in future asthma studies |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | February 2014 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00839748 | ||||||||
| Other Study ID Numbers ICMJE | 2003H0221 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | John Mastronarde, MD, Ohio State University | ||||||||
| Study Sponsor ICMJE | Ohio State University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ohio State University | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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