Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Characterising the Microbiota in Asthma (MIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671773
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date September 25, 2014
First Posted Date February 2, 2016
Last Update Posted Date February 2, 2016
Study Start Date June 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2016)
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs subject BTS treatment step [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 1, 2016)
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs FEV1 [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs FEV1 [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs sputum differential cell count (%eosinophils/%neutrophils) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs sputum differential cell count (%eosinophils/%neutrophils) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs exhaled nitric oxide level (ppb) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs exhaled nitric oxide level (ppb) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v PC20 (mg/ml) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v PC20 (mg/ml) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Leicester Cough Questionnaire (LCQ) score [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Leicester Cough Questionnaire (LCQ) score [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v Asthma Control Questionnaire Score [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v Asthma Control Questionnaire Score [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)) [ Time Frame: 1 day ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) stability over 24 hour period [ Time Frame: 2 days ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) stability over 24 hour period [ Time Frame: 2 days ]
  • Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) over 2 week period [ Time Frame: 2 weeks ]
  • Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) over 2 week period [ Time Frame: 2 weeks ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs subject BTS treatment step vs FEV1 [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs sputum differential cell count (%eosinophils/%neutrophils) [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs exhaled nitric oxide level (ppb) [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs PC20 (mg/ml) [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Leicester Cough Questionnaire (LCQ) score [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) vs Asthma Control Questionnaire Score [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) in patients on inhaled fluticasone v same measure in patients on inhaled budesonide [ Time Frame: 1 day ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) stability over 24 hour period [ Time Frame: 2 days ]
  • Subject sputum bacterial load as per qPCR quantitation (log10 copy numbers/g or similar) v conventional diagnostic microbiological culture (frequency of microbiological cultures reported as positive (%)) [ Time Frame: 1 day ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterising the Microbiota in Asthma
Official Title Characterising the Microbiota in Asthma
Brief Summary

Previous work has determined that there are significant differences in the communities of bacteria found in the airways of asthmatic patients compared to those found in the airways of healthy people.

It is not yet clear if these bacterial communities are similar in all patients with asthma or if they are different in people with more severe asthma, with different types of asthma or between asthma patients taking different treatment. This is important to know as any differences in the bacteria present between groups may help to explain why people with asthma do not have the same features of disease.

This research aims to determine if there are any differences in the number and type of bacteria found in the airways of asthmatic patients (1) with different severities of asthma and (2) who use different types of inhaled steroid treatment for asthma.

We will do this by detecting the DNA of bacteria present in phlegm samples from these patients. We will also take measurements of the different components of asthma to see if the bacteria are different in people with different types of disease.

As it is not yet clear if the bacteria detected in phlegm samples from one person may differ on different occasions, we will be taking more than one sample from some patients to see how similar this is over time.

Detailed Description

The main aim of this project is to determine if microbiota composition is correlated with disease severity (as determined by BTS step). Although initial studies suggest that asthmatics of different severities may have similar microbiota composition, there is no direct evidence to support this assertion. Also, the three main studies in this area so far have all used different sequencing methods, making comparisons difficult.

The relationship between the microbiota composition of different subjects and clinical measures including bronchial hyperreactivity (as measured by methacholine challenge) and pattern of airway inflammation (as measured by sputum differential cell count and exhaled nitric oxide levels) will be investigated further. Comparisons will also be made between samples from asthmatic patients using the inhaled steroid fluticasone and those using budesonide, as there is evidence suggesting that fluticasone leads to an increased risk of pneumonia and non tuberculous mycobacterial disease in certain patient groups. Unpublished data (Astra Zeneca) suggests the excess risk of pneumonia with fluticasone compared to budesonide may be more pronounced after at least 12 months of treatment with inhaled corticosteroid. Microbiota composition of the sputum samples will be evaluated in conjunction with standard microbiological culture of these samples to allow a comparison between these two methods.

In order to assess the reproducibility of the induced sputum method for assessing the lung microbiota, a repeat sputum sample will be taken from a subgroup of 20 patients within 24 hours of the collection of the first sample and compared. A further sample will be taken from this subgroup of patients 2 weeks later to assess the longitudinal stability of the bacterial population.

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sputum samples to be retained containing bacterial DNA
Sampling Method Non-Probability Sample
Study Population Adult asthmatic patients on Step 2 or Step 4 of the British Thoracic Society Asthma stepwise management protocol for asthma whose details are stored on the Nottingham Respiratory Research Patient Database or who attend respiratory clinics at the Nottingham City Hospital
Condition Asthma
Intervention Drug: Inhaled corticosteroid dose/type
Study Groups/Cohorts
  • BTS Step 2 Asthmatic patients
    Group of 20 asthmatic patients on British Thoracic Society (BTS) treatment step 2 - regular low dose inhaled corticosteroids (dose of <400 micrograms/day BDP equivalent)
    Intervention: Drug: Inhaled corticosteroid dose/type
  • BTS Step 4 Asthmatic patients on treatment with fluticasone
    Group of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled fluticasone (dose of >500 micrograms/day)
    Intervention: Drug: Inhaled corticosteroid dose/type
  • BTS Step 4 Asthmatic patients on treatment with budesonide
    Group of 15 asthmatic patients on British Thoracic Society (BTS) treatment step 4 - high dose inhaled budesonide (dose of >800 micrograms/day)
    Intervention: Drug: Inhaled corticosteroid dose/type
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2016)
72
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 18 or above
  • Male or female
  • Diagnosis of asthma
  • Non-smokers for 10 years and <10 pack year equivalents in total
  • BTS Step 2 patients must have been using inhaled steroids at a dose of BDP ≤ 400 mcg/day FP ≤ 200 mcg/day or BUD ≤ 400 mcg/day for at least 1 year
  • BTS Step 4 patients must have been using inhaled steroids at a dose of FP ≥ 500 mcg/day or BUD ≥800 mcg/day for at least 1 year as a separate steroid or inhaled steroid/long acting beta agonist combination.

Exclusion Criteria:

  • Respiratory infection or antibiotics within last month
  • Pregnancy or intent to become pregnant during course of study
  • Other respiratory diagnosis
  • Post bronchodilator FEV1 of < 60%
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02671773
Other Study ID Numbers 14016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Nottingham
Study Sponsor University of Nottingham
Collaborators King's College London
Investigators Not Provided
PRS Account University of Nottingham
Verification Date January 2016