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- Klinische proef NCT02887911
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
For all subjects:
Inclusion criteria:
- Men/Women, ages 18-75, with or without current asthma, are eligible to be screened.
Exclusion criteria:
- Cigarette smoking history of >30 total pack-years
- Current use of other smoked products or recreational drugs (e.g. pipes, cigars, e-cigarettes, other illicit drugs)
- History of lung disease other than asthma
- Recent upper respiratory tract infection treated with antibiotics within 8 weeks of visit 1
- Recent antibiotic use (except topical or ocular) within 8 weeks of visit 1 (chronic antibiotic use for asthma management allowed)
- Currently pregnant or breast-feeding
- Other medical conditions or treatments that may increase subject risk or affect study results, based on study physician judgment. These include the following: significant cardiovascular disease(+/- active symptoms), arrhythmia, or stroke, active cancer, post-organ transplant
- Any other condition for which subject is taking immunosuppressive therapies (except steroids for asthma)
- History of allergy to albuterol or methacholine
For asthma subjects only:
Note: Enrollment target is for 90 asthmatics already taking inhaled corticosteroids prescribed by their physician (any formulation and dose) and 60 subjects who are not currently using inhaled corticosteroid.
Additional inclusion criteria:
- History of asthma symptoms within the last 2 years (e.g. wheeze, shortness of breath, etc.)
- Evidence of stable asthma as assessed by initial screening
- No changes in asthma medications within 30 days of visit 1
- Methacholine PC20 (dose at which there is a 20 percent change) ≤ 8 mg/ml (for those asthmatics on inhaled steroids, PC20 ≤ 16 mg/ml), or change in FEV1 (forced expiratory volume in first second of spirometry effort)≥ 12% after 4 puffs of albuterol on reversibility testing (or PI discretion)
- If negative methacholine challenge or no evidence of bronchodilator reversibility, a strong history of physician-diagnosed/physician-managed asthma may allow for study inclusion, based on PI's judgement or discretion.
- Individuals with a history of physician-diagnosed asthma who have had bronchodilator reversibility testing or methacholine challenge performed within 60 days of screening may be enrolled and these existing test results used in lieu of repeating the same test at visit 1 or visit 2.
Additional exclusion criteria:
- An asthma exacerbation requiring treatment with oral or IV steroids within 1 month of visit 1
- No asthma symptoms within the last 2 years
- For healthy control or atopic non-asthma subjects:
Additional exclusion criteria:
- Evidence of abnormal lung function by any of the following: FEV1/FVC ratio <0.70, FEV1 or FVC (forced vital capacity on spirometry) < 80% predicted, methacholine PC20 < 16 mg/ml, or FEV1 improvement > 12% in response to albuterol
- Atopic non-asthma subjects found to have evidence of abnormal lung function, but without a clear or recent history of asthma, may be enrolled per PI's discretion.
- Possible pulmonary disease is identified by PI or Co-Is to explain an abnormal lung function result at the time of testing. The subject may be re-screened later at investigator's discretion.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Asthmatic, not taking inhaled steroids
Men/Women, ages 18-75 who are not currently taking corticosteroids..
No intervention; this is a prospective observational study.
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Asthmatic, taking inhaled steroids
Men/Women, ages 18-75 who are already taking corticosteroids prescribed by their physician.
No intervention; this is a prospective observational study.
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Healthy, non-asthmatic without allergies
Men/Women, ages 18-75 without a current diagnosis of asthma and no allergies.
No intervention; this is a prospective observational study.
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Healthy, atopic non-asthmatic
Men/Women, ages 18-75 with allergies but without a current diagnosis of asthma.
No intervention; this is a prospective observational study.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To characterize adult subjects with asthma in multiple domains, including disease severity and control, patterns of airway inflammation, microbial exposures and patterns of airway and gut microbial colonization
Tijdsspanne: Day 1" for the first one and "up to 60 days"
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Day 1" for the first one and "up to 60 days"
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To evaluate differences in airway and gut microbiota composition related to inhaled corticosteroid use (ICS) among asthmatics already regularly taking ICS, asthmatics not taking ICS, and healthy controls
Tijdsspanne: Day 1" for the first one and "up to 60 days"
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Day 1" for the first one and "up to 60 days"
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To apply culture and molecular methods to study functions of asthma-associated airway microbiota in corticosteroid-enriched environments
Tijdsspanne: Day 1" for the first one and "up to 60 days"
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Day 1" for the first one and "up to 60 days"
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To evaluate the temporal stability of the airway microbiome in asthmatic and healthy subjects
Tijdsspanne: Day 1" for the first one and "up to 60 days"
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Day 1" for the first one and "up to 60 days"
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To explore relationships between airway and gut microbiome composition in asthma, including among obese subjects
Tijdsspanne: Day 1" for the first one and "up to 60 days"
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Day 1" for the first one and "up to 60 days"
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yvonne J. Huang, MD, University of Michigan
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00097163
- 5R01AI129958 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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