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

17 november 2016 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

84

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Hälsosam kontroll
Experimentell: Inhaled corticosteroid
Fluticasone (250 mcg/puff, one puff, twice a day)
Läkemedel: fluticasone
Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
Andra namn:
  • Flovent 250
Placebo-jämförare: Placebo
Placebo fluticasone (one puff, twice a day)
Läkemedel: Placebo
Dry Powder Inhaler: Placebo
Inget ingripande: Atopic Non-asthmatics

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Microbial Community Richness
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Milton S. Hershey Medical Center

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

9 februari 2012

Först inskickad som uppfyllde QC-kriterierna

16 februari 2012

Första postat (Uppskatta)

23 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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