- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01537133
Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment
There are new, very sensitive methods for detecting bacteria. These methods show that hundreds of millions of microbes (organisms that can only be seen with microscopes), especially bacteria, live in healthy people. The collection of different microbes found in a site is called a "microbiome." The investigators know that microbiomes of the skin, sinuses, mouth, gastro-intestinal tract, etc. differ from each other. The make-up of the microbiome - which bacteria are found in a site - may be necessary for good health. For example, the microbiome of the mouth is different in people with inflammation of the gums (periodontitis), and the microbiome of the bowel is different in people with inflammation of the intestinal tract (inflammatory bowel disease).
The purpose of this research study is to find out if the microbiome in the lungs is different in healthy people without asthma compared to people with asthma. This study will also find out if the microbiome of the lungs changes when people with asthma take a daily "controller" medication called an inhaled corticosteroid.
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94143-0130
- University of California, San Francisco, Adult
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Colorado
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Denver, Colorado, Stati Uniti, 80206
- National Jewish Health
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham & Women's Hospital
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Missouri
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St. Louis, Missouri, Stati Uniti, 63110
- Washington University
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North Carolina
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Durham, North Carolina, Stati Uniti, 27110
- Duke University School of Medicine
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Health Sciences
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh, Adult
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53972
- University of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Asthmatic:
- History of physician-diagnosed asthma.
- Methacholine PC20 < 8mg/ml and/or FEV1 improvement ≥ 12% in response to 180 mcg albuterol.
- FEV1 ≥ 70% of predicted after 180 mcg albuterol.
- Stable asthma for ≥ 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).
- Asthma Control Questionnaire 6 Score < 1.5.
- Able to provide informed consent.
- Able to perform spirometry as per ATS criteria.
- Evidence by allergen skin test of sensitivity to an aeroallergen.
- Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
Healthy Control:
- Evidence by allergen skin test of sensitivity to an aeroallergen.
- Able to provide informed consent.
- Able to perform spirometry as per ATS criteria.
Exclusion Criteria:
Asthmatic:
- Presence of lung disease other than asthma.
- Use of > 10 doses of nasal corticosteroids in the previous 3 months.
- Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
- History of atrial or ventricular tachyarrhythmia.
- Changes suggestive of cardiac ischemia on ECG at baseline.
- History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
- History of chronic sinus disease.
- Smoking > 5 pack-years, or within the past year
- History of long-term controller medication use for asthma (inhaled or oral corticosteroid, leukotriene pathway antagonist, cromolyn, or theophylline within the preceding 6 months.
- History of bleeding disorder.
- Reduced creatinine clearance.
- Inability, in the opinion of the Study Investigator, to coordinate use of inhaler or otherwise comply with medication regimens.
- Contraindication to bronchoscopy on history or examination.
Healthy Control:
- History of chronic respiratory disease including asthma.
- Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
- History of atrial or ventricular tachyarrhythmia.
- Changes suggestive of cardiac ischemia on ECG at baseline.
- History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
- Methacholine PC20 < 16 mg/ml or FEV1 improvement ≥ 12% in response to albuterol.
- History of chronic sinus disease
- Smoking > 5 pack-years, or within the past year
- Use of > 10 doses of a nasal corticosteroid preparation in the previous 3 months
- FEV1 or FVC < 80% predicted.
- History of bleeding disorder.
- Reduced creatinine clearance.
- Contraindication to bronchoscopy on history or examination.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: Controllo sano
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Sperimentale: Inhaled corticosteroid
Fluticasone (250 mcg/puff, one puff, twice a day)
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Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
Altri nomi:
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Comparatore placebo: Placebo
Placebo fluticasone (one puff, twice a day)
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Dry Powder Inhaler: Placebo
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Nessun intervento: Atopic Non-asthmatics
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Microbial Community Richness
Lasso di tempo: baseline and after 6 weeks of treatment
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Richness is the total number of different bacterial taxa detected in the sample.
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baseline and after 6 weeks of treatment
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Microbial Community Diversity
Lasso di tempo: baseline and after 6 weeks of treatment
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The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species.
If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i).
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baseline and after 6 weeks of treatment
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Microbial Community Evenness
Lasso di tempo: baseline and after 6 weeks of treatment
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Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant.
Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.
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baseline and after 6 weeks of treatment
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lewis Smith, MD, Northwestern Memorial Hospital
- Investigatore principale: Richard Martin, MD, National Jewish Health
- Investigatore principale: Christine Sorkness, MD, University of Wisconsin, Madison
- Investigatore principale: Sally Wenzel, MD, University of Pittsburgh Medical Center
- Investigatore principale: Stephen Peters, MD, Wake Forest University Health Sciences
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Malattie polmonari
- Ipersensibilità, immediata
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità
- Asma
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti dermatologici
- Agenti broncodilatatori
- Agenti antiasmatici
- Agenti del sistema respiratorio
- Agenti antiallergici
- Fluticasone
Altri numeri di identificazione dello studio
- AsthmaNet 003
- U10HL098115 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .
Prove cliniche su fluticasone
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Creighton UniversityRoche Pharma AGCompletato