- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02887911
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
---|---|
To apply culture and molecular methods to study functions of asthma-associated airway microbiota in corticosteroid-enriched environments
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yvonne J. Huang, MD, University of Michigan
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM00097163
- 5R01AI129958 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .