Characterising the Microbiota in Asthma

NCT02671773 | Completed

• 1 other identifier: 14016
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Microbiota

Outcome Measures

Primary Outcomes (2)

• Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs subject BTS treatment step

  1 day

• Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs subject BTS treatment step

  1 day

Secondary Outcomes (30)

• Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs FEV1

  1 day

• Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs FEV1

  1 day

• Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs sputum differential cell count (%eosinophils/%neutrophils)

  1 day

• Subject sputum microbiota bacterial diversity (as quantified by Simpson's diversity index) vs sputum differential cell count (%eosinophils/%neutrophils)

  1 day

• Subject sputum microbiota bacterial diversity (richness) (as quantified by mean number of genera) vs exhaled nitric oxide level (ppb)

  1 day

Study Arms (3)

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)

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)

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)

Drug: Inhaled corticosteroid dose/type

Interventions

Inhaled corticosteroid dose/type DRUG

BTS Step 2 Asthmatic patients; BTS Step 4 Asthmatic patients on treatment with budesonide; BTS Step 4 Asthmatic patients on treatment with fluticasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator

Study Sites (1)

Respiratory Research Unit

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Related Publications (1)

• Martin MJ, Zain NMM, Hearson G, Rivett DW, Koller G, Wooldridge DJ, Rose G, Gharbia SE, Forbes B, Bruce KD, Harrison TW. The airways microbiome of individuals with asthma treated with high and low doses of inhaled corticosteroids. PLoS One. 2020 Dec 30;15(12):e0244681. doi: 10.1371/journal.pone.0244681. eCollection 2020.

  PMID: 33378384 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Sputum samples to be retained containing bacterial DNA

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: February 2, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

GB (1)