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Airway Microbiome in Asthma: Relationships to Asthma Phenotype and Inhaled Corticosteroid Treatment

17. november 2016 oppdatert av: dave mauger, Milton S. Hershey Medical Center

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Two broad specific aims of this study are: 1)To evaluate whether the microbiota of the bronchial airways in atopic asthmatics and atopic healthy controls differ in microbial diversity, richness, evenness, or composition of specific bacterial taxa. 2) To determine whether inhaled corticosteroid treatment alters bronchial microbial community composition in asthmatics.

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94143-0130
        • University of California, San Francisco, Adult
    • Colorado
      • Denver, Colorado, Forente stater, 80206
        • National Jewish Health
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham & Women's Hospital
    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
        • Washington University
    • North Carolina
      • Durham, North Carolina, Forente stater, 27110
        • Duke University School of Medicine
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh, Adult
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53972
        • University of Wisconsin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Sunn kontroll
Eksperimentell: Inhaled corticosteroid
Fluticasone (250 mcg/puff, one puff, twice a day)
Legemiddel: fluticasone
Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
Andre navn:
  • Flovent 250
Placebo komparator: Placebo
Placebo fluticasone (one puff, twice a day)
Legemiddel: Placebo
Dry Powder Inhaler: Placebo
Ingen inngripen: Atopic Non-asthmatics

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Microbial Community Richness
Tidsramme: baseline and after 6 weeks of treatment
Richness is the total number of different bacterial taxa detected in the sample.
baseline and after 6 weeks of treatment
Microbial Community Diversity
Tidsramme: baseline and after 6 weeks of treatment
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).
baseline and after 6 weeks of treatment
Microbial Community Evenness
Tidsramme: baseline and after 6 weeks of treatment
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.
baseline and after 6 weeks of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Milton S. Hershey Medical Center

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

  • Hovedetterforsker: Lewis Smith, MD, Northwestern Memorial Hospital
  • Hovedetterforsker: Richard Martin, MD, National Jewish Health
  • Hovedetterforsker: Christine Sorkness, MD, University of Wisconsin, Madison
  • Hovedetterforsker: Sally Wenzel, MD, University of Pittsburgh Medical Center
  • Hovedetterforsker: Stephen Peters, MD, Wake Forest University Health Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

9. februar 2012

Først innsendt som oppfylte QC-kriteriene

16. februar 2012

Først lagt ut (Anslag)

23. februar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. november 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AsthmaNet 003
  • U10HL098115 (U.S. NIH-stipend/kontrakt)

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