xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06028204</url>
    </required_header>
    <id_info>
      <org_study_id>23.29</org_study_id>
      <nct_id>NCT06028204</nct_id>
    </id_info>
    <brief_title>This is a 6-month Observational Study. Patients Included Will be Those Referred With a Possible Diagnosis or an Established Diagnosis of Asthma. It Will Look at the Association of the Asthma Microbiome and Disease Characteristics, Severity and Treatment Response.</brief_title>
    <official_title>The Role of the Lung Microbiome in Asthma and Its Influence on Treatment Response.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal College of Surgeons, Ireland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Charitable Infirmary Charitable Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>New York University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Royal College of Surgeons, Ireland</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to investigate the role of the lung microbiome in&#xD;
        patients with asthma and how it may influence the response to asthma specific treatments.&#xD;
        This will be compared to patients who presented similarly but do not have a diagnosis of&#xD;
        asthma.&#xD;
  &#xD;
        The main aims are to:&#xD;
  &#xD;
          1. Evaluate the influence of the microbiome on asthma phenotypes&#xD;
  &#xD;
          2. Evaluate the influence of the microbiome on respiratory physiological change&#xD;
  &#xD;
          3. Evaluate the effect of asthma treatment on the microbiome and the host response&#xD;
  &#xD;
        Participants will be asked to provide a medical history focusing on their asthma and related&#xD;
        co-morbidities such as sinus and reflux disease. They will have physiological parameters&#xD;
        measured (spirometry, impulse oscillometry, fraction of exhaled nitric oxide). They will have&#xD;
        samples collected to assess the upper and lower airway microbiome (oral rinse, nasopharyngeal&#xD;
        swab, sputum, exhaled breath condensate and bronchoscopy) as well as the gut microbiome&#xD;
        (stool). They will also have serum samples taken to perform host immune profiling (host&#xD;
        transcriptome). They will be followed over six months observing how changes to asthma&#xD;
        specific treatments, particularly inhaled corticosteroids and biologic agents can affect the&#xD;
        microbiome&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        VISIT 1 (Month 0) FACE TO FACE&#xD;
  &#xD;
          -  Once consented a study ID will be assigned, and basic demographic information taken.&#xD;
  &#xD;
          -  A standardized medical history will be taken to include target symptom history,&#xD;
             exacerbation frequency and hospital admissions.&#xD;
  &#xD;
          -  A detailed co-morbid history will be taken as will a review of all previous asthma&#xD;
             treatments. Validated symptom questionnaires will be completed during the study visits.&#xD;
  &#xD;
          -  All participants will be given an electronic PEFR monitor.&#xD;
  &#xD;
          -  Patients on or planned for inhaled therapy will be given an electronic adherence&#xD;
             monitor.&#xD;
  &#xD;
          -  Pulmonary function testing will be performed including Spirometry, Impulse Oscillometry,&#xD;
             Fraction of exhaled Nitric Oxide along with bronchodilator reversibility.&#xD;
  &#xD;
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, exhaled breath&#xD;
             condensate, stool and induced sputum.&#xD;
  &#xD;
          -  A subset of patients will be consented for bronchoscopy for lower airway sampling.&#xD;
  &#xD;
        VISIT 2,3, 4 (Month 1,2, 3) FACE TO FACE&#xD;
  &#xD;
          -  A detailed history of symptoms will be taken as will a review of all treatment changes.&#xD;
  &#xD;
          -  Validated symptom questionnaires will be completed during the study visits.&#xD;
  &#xD;
          -  PEFR and adherence device data from the previous month will be collected and new&#xD;
             monitors and devices provided where needed.&#xD;
  &#xD;
          -  Pulmonary function testing will be performed as above.&#xD;
  &#xD;
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, EBC, stool and&#xD;
             induced sputum as above.&#xD;
  &#xD;
        VISIT 5 (Month 6) FACE TO FACE&#xD;
  &#xD;
          -  A detailed history of symptoms will be taken as will a review of all treatment changes.&#xD;
             - Validated symptom questionnaires will be completed during the study visits.&#xD;
  &#xD;
          -  PEFR and adherence device data from the previous month will be collected and new&#xD;
             monitors and devices provided where needed.&#xD;
  &#xD;
          -  Pulmonary function testing will be performed as above.&#xD;
  &#xD;
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, EBC, stool and&#xD;
             induced sputum.&#xD;
  &#xD;
          -  A subset of patients who had bronchoscopy at VISIT 1 will have bronchoscopy performed&#xD;
             again for corresponding sample collection.&#xD;
  &#xD;
        PROCEDURES:&#xD;
  &#xD;
        Questionnaires:&#xD;
  &#xD;
        Validated symptom questionnaires will be completed during the study visits indicated&#xD;
        previously. Asthma Control Test measures the adequacy of asthma control and change in asthma&#xD;
        control which may occur spontaneously or in response to treatment. The GERD-Q and the SNOT-22&#xD;
        establish the presence and severity of co-morbid Gastro-oesophageal reflux disease and sinus&#xD;
        disease, both common asthma co-morbidities, which may affect quality of life, symptom control&#xD;
        and treatment response.&#xD;
  &#xD;
        Investigations:&#xD;
  &#xD;
        Pulmonary function testing will include spirometry, impulse oscillometry (IOS), Peak&#xD;
        Expiratory Flow Rate (PEFR) measurement. Fraction of exhaled Nitric Oxide (FeNO), an&#xD;
        established biomarker measured routinely in asthma clinics, will also be measured.&#xD;
  &#xD;
        Bio-samples:&#xD;
  &#xD;
        Background samples will be taken from sampling and storage equipment to examine for&#xD;
        environmental contamination including sterile saline, nasopharyngeal swab, oral rinse/sputum&#xD;
        pot container and the bronchoscope.&#xD;
  &#xD;
        Blood tests will be drawn via phlebotomy and a single needle pass. The total quantity of&#xD;
        blood volume drawn will be the minimally acceptable volume used in paediatric patients for&#xD;
        research purposes. Maximum total sample volume is 50ml/10 teaspoons.&#xD;
  &#xD;
        Oral samples will be collected using a standardized procedure in accordance with the Manual&#xD;
        of Procedures for Human Microbiome Project. Study participants will rinse their mouth&#xD;
        (swish/gargle) with 15 mL sterile normal saline for 1 min and will expectorate the contents&#xD;
        of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until&#xD;
        processing.&#xD;
  &#xD;
        Nasopharyngeal swab will be collected inserted into each nostril for several seconds.&#xD;
  &#xD;
        Induced sputum will be collected in selected patients using hypertonic saline where needed.&#xD;
  &#xD;
        EBC will be collected using RTube where a one way breathing valve that allows contaminant&#xD;
        free collection of 200 microlitres per minute in adults during normal breathing.&#xD;
  &#xD;
        Stool will be collected in a sealable container and stored at -80 for further processing.&#xD;
  &#xD;
        Bronchoscopy will be performed under moderate sedation with topical anaesthesia. A small&#xD;
        camera is passed through the vocal cords into the upper then lower airways. For a&#xD;
        bronchoalveolar lavage (BAL) a total of 60ml of normal saline will be instilled into a&#xD;
        pulmonary lobe and the return will be collected for analysis. An endothelial brushing (EB)&#xD;
        involves the introduction of a small brush via the bronchoscope to gently brush the airway&#xD;
        walls to collect epithelial cells for analysis for morphological and functional studies.&#xD;
  &#xD;
        SAMPLE PROCESSING:&#xD;
  &#xD;
        Samples will be processed and stored in RCSI. Once all collected, the available samples will&#xD;
        be transferred to New York University Hospitals (for our collaborator Dr. Leopoldo Segal), to&#xD;
        be processed for microbiome and host transcriptome profiling.&#xD;
  &#xD;
        Blood samples will be processed for complete blood count, immunoglobulin E and aeroallergen&#xD;
        sensitivity. In addition blood will be processed for host immune profiling.&#xD;
  &#xD;
        Background control, oral rinse, nasopharyngeal swab, EBC, induced sputum and stool samples&#xD;
        will be processed for microbiome. EBC and induced sputum will also be processed for host&#xD;
        immune profiling.&#xD;
  &#xD;
        From the bronchoscopy cohort, all collected samples will undergo microbiome analysis. We will&#xD;
        also perform host immune profiling on BAL samples. Endobronchial brushes will be processed&#xD;
        for host transcriptome analysis.&#xD;
  &#xD;
          -  Host immune profiling: Cytokine analysis of samples will be done by Luminex multiplex&#xD;
  &#xD;
          -  16S rRNA gene sequencing (microbiome): Nucleic acid extraction, 16S rRNA gene&#xD;
             amplification, and purification will be performed and sequencing will be performed on a&#xD;
             MiSeq platform (Illumina). This data will be analysed with Quantitative Insights Into&#xD;
             Microbial Ecology (QIIME).&#xD;
  &#xD;
          -  Bulk RNAseq (host transciptome): RNAseq will be performed on bronchial epithelial cells&#xD;
             obtained by bronchial brushing (EB), using the Hi-seq /Illumina platform. Sequences will&#xD;
             be aligned against the hg19 ensemble reference genome, subsequent gene counting will be&#xD;
             performed using featureCounts and differential gene expression will be calculated using&#xD;
             the DESeq2 package with an adjusted p-value &lt;0.05. Ingenuity Pathway Analysis (IPA) will&#xD;
             used to identify top biological functions. Genes will be mapped to Ensembl IDs and&#xD;
             subsequently to KEGG pathways. We will also use analytical approaches designed to&#xD;
             establish an immunological profiling such as CIBERSORT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Describe microbiome signature across the spectrum of asthma severity</measure>
      <time_frame>2 years</time_frame>
      <description>We expect an increasingly dysbiotic signature in the respiratory microbiome of patients with severe asthma.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Establish if there is any association between asthma phenotype and microbiome signature</measure>
      <time_frame>2 years</time_frame>
      <description>We expect to see a correlation between dysbiosis in the respiratory microbiome and changes in symptom control and physiological parameters.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine whether microbiome signature can predict treatment response or resistence</measure>
      <time_frame>2 years</time_frame>
      <description>We expect to identify a microbial signature in the respiratory microbiome associated with treatment response, to both biological therapy as well as inhaled corticosteroids.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Asthma</condition>
    <arm_group>
      <arm_group_label>Biologic Naïve Group</arm_group_label>
      <description>This will aim to include 50 patients who have been referred with possible asthma or have a diagnosis of asthma, and are established on treatment in the form of bronchodilators and/or inhaled corticosteroids who are not candidates for biologic therapy at present</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biologic Group</arm_group_label>
      <description>This will aim to include 10 patients who have been referred with an established diagnosis of asthma and are on treatment in the form of bronchodilators and/or inhaled corticosteroids and have been selected as suitable candidates for commencing biologic therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Biologic Agent</intervention_name>
      <description>Biologic group will have biological agent commenced if considered necessary as part of routine care.</description>
      <arm_group_label>Biologic Group</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Once all collected, the available samples will be processed for microbiome and host&#xD;
        transcriptome profiling. Blood samples will be processed for complete blood count,&#xD;
        immunoglobulin E and aeroallergen sensitivity. In addition blood will be processed for host&#xD;
        immune profiling. Background control, oral rinse, nasopharyngeal swab, exhaled breath&#xD;
        condensate, induced sputum and stool samples will be processed for microbiome. EBC and&#xD;
        induced sputum will also be processed for host immune profiling. From the bronchoscopy&#xD;
        cohort, all collected samples will undergo microbiome analysis. We will also perform host&#xD;
        immune profiling on BAL samples. Endobronchial brushes will be processed for host&#xD;
        transcriptome analysis.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patient referred with a possible diagnosis of asthma or established diagnosis of asthma to&#xD;
          hospital or the Respiratory Outpatient Department&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients ≥18 years&#xD;
  &#xD;
            -  Patients able to give informed consent&#xD;
  &#xD;
            -  Patients who have been referred with possible asthma or have an established diagnosis&#xD;
               of asthma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients &lt;18 years&#xD;
  &#xD;
            -  Patients unable to give informed consent&#xD;
  &#xD;
            -  Patients who are or intend to become pregnant during the study period&#xD;
  &#xD;
            -  Other co-existent respiratory diagnosis e.g. bronchiectasis, COPD, Pulmonary fibrosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Margaret Gleeson, MB BCh BAO</last_name>
      <phone>+353871712690</phone>
      <email>margaretgleeson@rcsi.ie</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Imran Sulaiman, MB BCh BAO</last_name>
      <phone>+353863840469</phone>
      <email>imransulaiman@rcsi.ie</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>If coded data were to be used again, further patient consent, ethical and data protection approval would be required.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06028204
  org study id: 23.29
  nct id: NCT06028204
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this observational study is to investigate the role of the lung microbiome in
        patients with asthma and how it may influence the response to asthma specific treatments.
        This will be compared to patients who presented similarly but do not have a diagnosis of
        asthma.
  
        The main aims are to:
  
          1. Evaluate the influence of the microbiome on asthma phenotypes
  
          2. Evaluate the influence of the microbiome on respiratory physiological change
  
          3. Evaluate the effect of asthma treatment on the microbiome and the host response
  
        Participants will be asked to provide a medical history focusing on their asthma and related
        co-morbidities such as sinus and reflux disease. They will have physiological parameters
        measured (spirometry, impulse oscillometry, fraction of exhaled nitric oxide). They will have
        samples collected to assess the upper and lower airway microbiome (oral rinse, nasopharyngeal
        swab, sputum, exhaled breath condensate and bronchoscopy) as well as the gut microbiome
        (stool). They will also have serum samples taken to perform host immune profiling (host
        transcriptome). They will be followed over six months observing how changes to asthma
        specific treatments, particularly inhaled corticosteroids and biologic agents can affect the
        microbiome
  VISIT 1 (Month 0) FACE TO FACE
  
          -  Once consented a study ID will be assigned, and basic demographic information taken.
  
          -  A standardized medical history will be taken to include target symptom history,
             exacerbation frequency and hospital admissions.
  
          -  A detailed co-morbid history will be taken as will a review of all previous asthma
             treatments. Validated symptom questionnaires will be completed during the study visits.
  
          -  All participants will be given an electronic PEFR monitor.
  
          -  Patients on or planned for inhaled therapy will be given an electronic adherence
             monitor.
  
          -  Pulmonary function testing will be performed including Spirometry, Impulse Oscillometry,
             Fraction of exhaled Nitric Oxide along with bronchodilator reversibility.
  
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, exhaled breath
             condensate, stool and induced sputum.
  
          -  A subset of patients will be consented for bronchoscopy for lower airway sampling.
  
        VISIT 2,3, 4 (Month 1,2, 3) FACE TO FACE
  
          -  A detailed history of symptoms will be taken as will a review of all treatment changes.
  
          -  Validated symptom questionnaires will be completed during the study visits.
  
          -  PEFR and adherence device data from the previous month will be collected and new
             monitors and devices provided where needed.
  
          -  Pulmonary function testing will be performed as above.
  
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, EBC, stool and
             induced sputum as above.
  
        VISIT 5 (Month 6) FACE TO FACE
  
          -  A detailed history of symptoms will be taken as will a review of all treatment changes.
             - Validated symptom questionnaires will be completed during the study visits.
  
          -  PEFR and adherence device data from the previous month will be collected and new
             monitors and devices provided where needed.
  
          -  Pulmonary function testing will be performed as above.
  
          -  Sample collection will include blood, oral rinse, nasopharyngeal swab, EBC, stool and
             induced sputum.
  
          -  A subset of patients who had bronchoscopy at VISIT 1 will have bronchoscopy performed
             again for corresponding sample collection.
  
        PROCEDURES:
  
        Questionnaires:
  
        Validated symptom questionnaires will be completed during the study visits indicated
        previously. Asthma Control Test measures the adequacy of asthma control and change in asthma
        control which may occur spontaneously or in response to treatment. The GERD-Q and the SNOT-22
        establish the presence and severity of co-morbid Gastro-oesophageal reflux disease and sinus
        disease, both common asthma co-morbidities, which may affect quality of life, symptom control
        and treatment response.
  
        Investigations:
  
        Pulmonary function testing will include spirometry, impulse oscillometry (IOS), Peak
        Expiratory Flow Rate (PEFR) measurement. Fraction of exhaled Nitric Oxide (FeNO), an
        established biomarker measured routinely in asthma clinics, will also be measured.
  
        Bio-samples:
  
        Background samples will be taken from sampling and storage equipment to examine for
        environmental contamination including sterile saline, nasopharyngeal swab, oral rinse/sputum
        pot container and the bronchoscope.
  
        Blood tests will be drawn via phlebotomy and a single needle pass. The total quantity of
        blood volume drawn will be the minimally acceptable volume used in paediatric patients for
        research purposes. Maximum total sample volume is 50ml/10 teaspoons.
  
        Oral samples will be collected using a standardized procedure in accordance with the Manual
        of Procedures for Human Microbiome Project. Study participants will rinse their mouth
        (swish/gargle) with 15 mL sterile normal saline for 1 min and will expectorate the contents
        of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until
        processing.
  
        Nasopharyngeal swab will be collected inserted into each nostril for several seconds.
  
        Induced sputum will be collected in selected patients using hypertonic saline where needed.
  
        EBC will be collected using RTube where a one way breathing valve that allows contaminant
        free collection of 200 microlitres per minute in adults during normal breathing.
  
        Stool will be collected in a sealable container and stored at -80 for further processing.
  
        Bronchoscopy will be performed under moderate sedation with topical anaesthesia. A small
        camera is passed through the vocal cords into the upper then lower airways. For a
        bronchoalveolar lavage (BAL) a total of 60ml of normal saline will be instilled into a
        pulmonary lobe and the return will be collected for analysis. An endothelial brushing (EB)
        involves the introduction of a small brush via the bronchoscope to gently brush the airway
        walls to collect epithelial cells for analysis for morphological and functional studies.
  
        SAMPLE PROCESSING:
  
        Samples will be processed and stored in RCSI. Once all collected, the available samples will
        be transferred to New York University Hospitals (for our collaborator Dr. Leopoldo Segal), to
        be processed for microbiome and host transcriptome profiling.
  
        Blood samples will be processed for complete blood count, immunoglobulin E and aeroallergen
        sensitivity. In addition blood will be processed for host immune profiling.
  
        Background control, oral rinse, nasopharyngeal swab, EBC, induced sputum and stool samples
        will be processed for microbiome. EBC and induced sputum will also be processed for host
        immune profiling.
  
        From the bronchoscopy cohort, all collected samples will undergo microbiome analysis. We will
        also perform host immune profiling on BAL samples. Endobronchial brushes will be processed
        for host transcriptome analysis.
  
          -  Host immune profiling: Cytokine analysis of samples will be done by Luminex multiplex
  
          -  16S rRNA gene sequencing (microbiome): Nucleic acid extraction, 16S rRNA gene
             amplification, and purification will be performed and sequencing will be performed on a
             MiSeq platform (Illumina). This data will be analysed with Quantitative Insights Into
             Microbial Ecology (QIIME).
  
          -  Bulk RNAseq (host transciptome): RNAseq will be performed on bronchial epithelial cells
             obtained by bronchial brushing (EB), using the Hi-seq /Illumina platform. Sequences will
             be aligned against the hg19 ensemble reference genome, subsequent gene counting will be
             performed using featureCounts and differential gene expression will be calculated using
             the DESeq2 package with an adjusted p-value <0.05. Ingenuity Pathway Analysis (IPA) will
             used to identify top biological functions. Genes will be mapped to Ensembl IDs and
             subsequently to KEGG pathways. We will also use analytical approaches designed to
             establish an immunological profiling such as CIBERSORT.
  observational model: Cohort
  time perspective: Prospective
  measure: Describe microbiome signature across the spectrum of asthma severity
  time frame: 2 years
  description: We expect an increasingly dysbiotic signature in the respiratory microbiome of patients with severe asthma.
  measure: Establish if there is any association between asthma phenotype and microbiome signature
  time frame: 2 years
  description: We expect to see a correlation between dysbiosis in the respiratory microbiome and changes in symptom control and physiological parameters.
  measure: Determine whether microbiome signature can predict treatment response or resistence
  time frame: 2 years
  description: We expect to identify a microbial signature in the respiratory microbiome associated with treatment response, to both biological therapy as well as inhaled corticosteroids.
  arm group label: Biologic Naïve Group
  description: This will aim to include 50 patients who have been referred with possible asthma or have a diagnosis of asthma, and are established on treatment in the form of bronchodilators and/or inhaled corticosteroids who are not candidates for biologic therapy at present
  arm group label: Biologic Group
  description: This will aim to include 10 patients who have been referred with an established diagnosis of asthma and are on treatment in the form of bronchodilators and/or inhaled corticosteroids and have been selected as suitable candidates for commencing biologic therapy.
  intervention type: Drug
  intervention name: Biologic Agent
  description: Biologic group will have biological agent commenced if considered necessary as part of routine care.
  arm group label: Biologic Group
  Once all collected, the available samples will be processed for microbiome and host
        transcriptome profiling. Blood samples will be processed for complete blood count,
        immunoglobulin E and aeroallergen sensitivity. In addition blood will be processed for host
        immune profiling. Background control, oral rinse, nasopharyngeal swab, exhaled breath
        condensate, induced sputum and stool samples will be processed for microbiome. EBC and
        induced sputum will also be processed for host immune profiling. From the bronchoscopy
        cohort, all collected samples will undergo microbiome analysis. We will also perform host
        immune profiling on BAL samples. Endobronchial brushes will be processed for host
        transcriptome analysis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Margaret Gleeson, MB BCh BAO
  phone: +353871712690
  email: margaretgleeson@rcsi.ie
  last name: Imran Sulaiman, MB BCh BAO
  phone: +353863840469
  email: imransulaiman@rcsi.ie
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: Undecided
  ipd description: If coded data were to be used again, further patient consent, ethical and data protection approval would be required.