Exhaled Breath Metabolomic Biomarkers in the Acutely Breathless Patient

NCT03672994 | Completed

• 1 other identifier: 0569
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

An acute study carried out across three acute admissions units within Leicestershire. The study is aimed at discovery and validation of volatile organic compounds (VOCs) in exhaled breath. Participants will be recruited and tested within 24 hours of admission and once recovered, up to 6 months following discharge.

Conditions

Asthma; COPD; Heart Failure; Community-acquired Pneumonia; Healthy; Breathlessness

Keywords

Acute Breathlessness; Breathomics

Outcome Measures

Primary Outcomes (1)

• Discovery of exhaled breath biomarkers

  To evaluate the sensitivity, specificity, positive and negative predictive value of metabolomic biomarkers in exhaled breath samples to identify acute breathlessness, defined as one or more of (i) patient defined acute breathlessness and/or a (ii) 1 unit increase in Extended Medical Research Council breathlessness score (eMRC)

  0-6 months

Secondary Outcomes (46)

• Patient defined breathlessness

  visit 1a (first visit), visit 2 (0-6 months)

• COPD Assessment Test (CAT) (Questionnaire)

  visit 1a (first visit), visit 2 (0-6 months)

• NASA task load index

  visit 1a (first visit), visit 2 (0-6 months)

• Asthma quality of life questionaire (AQLQ)

  visit 1a (first visit), visit 2 (0-6 months)

• Asthma control questionnaire (ACQ)

  visit 1a (first visit), visit 2 (0-6 months)

Study Arms (5)

Asthma

Patients with prior confirmed diagnosis of bronchial asthma

Chronic Obstructive Pulmonary Disease

Patients with prior confirmed COPD

Pneumonia

Patients with X-ray confirmed community acquired pneumonia

Heart failure

Patients with confirmed heart failure

Healthy volunteers

Healthy participants with no otherwise known cardiorespiratory condition

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective participants with self reported acute breathlessness, either requiring admission or a change in baseline treatment, presenting within University Hospitals of Leicester (UHL). Patients with confirmed acute airway exacerbation or heart failure decompensation as part of other research studies at the NIHR Leicester BRC may also be included. Age- and/or home environment matched adult/spousal/parent and sibling healthy volunteers will be recruited where possible on the admissions unit or in the research units across both sites at a separate visit. A stable state control population will also be recruited to compare with the unstable state. This will consist of participants with a confirmed diagnosis matched with the acute care population but not in the exacerbation state.

You may qualify if:

• (i) Able to give informed consent for participation in the study. (ii) Male or Female, aged 16 years or above (adult cohort) and 5-15 years for paediatric patients attending the acute care paediatric pathway.
• (iii) Capable (in the opinion of the EMBER clinical research investigator(s) of providing serial breath samples.
• (iv) Diagnosed with acute breathlessness as one of the primary indicator reasons by the clinical acute care team. This is not a requirement for healthy subjects or matched controls.
• (v) One of the indicator provisional diagnoses identified in section 7.1 following senior review by the clinical acute care team. This is not a requirement for healthy subjects or matched controls (vi) Able (in the Investigators opinion) and willing to comply with all study requirements.
• (vii) Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
• (viii) Ability to understand English.

You may not qualify if:

• (i) Female participants who are known to be pregnant, lactating or planning pregnancy during the course of the study.
• (ii) Current participation in a clinical trial of an investigative medicinal product or within 3 months or 5.5 half-lives of the IMP whichever is longer.
• (iii) Active or clinically suspected pulmonary tuberculosis (iv) In the opinion of the treating physician, breath sampling during the acute admission would be clinically unsafe or inappropriate due to the patient's condition or poor prognosis. Examples include malignancy or autoimmune disease with anticipated survival of under 1 year, and chronic renal replacement therapy.
• (v) Unable or unwilling to give informed consent by visit 1b. (vi) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• University of Leicester: lead
• Medical Research Council: collaborator
• Engineering and Physical Sciences Research Council, UK: collaborator
• Loughborough University: collaborator
• University Hospitals, Leicester: collaborator
• Owlstone Ltd: collaborator
• B & S ANALYTIK GmbH: collaborator
• Advion Biosciences Ltd: collaborator

Study Sites (1)

NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (1)

• Ibrahim W, Wilde M, Cordell R, Salman D, Ruszkiewicz D, Bryant L, Richardson M, Free RC, Zhao B, Yousuf A, White C, Russell R, Jones S, Patel B, Awal A, Phillips R, Fowkes G, McNally T, Foxon C, Bhatt H, Peltrini R, Singapuri A, Hargadon B, Suzuki T, Ng LL, Gaillard E, Beardsmore C, Ryanna K, Pandya H, Coates T, Monks PS, Greening N, Brightling CE, Thomas P, Siddiqui S. Assessment of breath volatile organic compounds in acute cardiorespiratory breathlessness: a protocol describing a prospective real-world observational study. BMJ Open. 2019 Mar 8;9(3):e025486. doi: 10.1136/bmjopen-2018-025486.

  PMID: 30852546 DERIVED

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Heart Failure; Community-Acquired Pneumonia; Dyspnea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Salman Siddiqui, Professor

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 17, 2018
• Study Start: February 2, 2017
• Primary Completion: December 30, 2018
• Study Completion: April 30, 2019
• Last Updated: January 30, 2020

Record last verified: 2018-08

Locations

GB (1)