AsthmaEMBERNCT03672994
Exhaled Breath Metabolomic Biomarkers in the Acutely Breathless Patient
An observational study of Asthma and COPD, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Heart Failure
- How many people
- 650 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- Capable (in the opinion of the EMBER clinical research investigator(s) of providing serial breath samples.
- 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.
- 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.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
- Ability to understand English.
Who cannot join
- Female participants who are known to be pregnant, lactating or planning pregnancy during the course of the study.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
About this study
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.
Read the detailed description
A prospective real world observational study carried out across three acute admissions units. Participants with self-reported acute breathlessness, with a confirmed primary diagnosis of either acute heart failure, community acquired pneumonia and acute exacerbation of asthma or COPD will be recruited within 24 hours of admission. These will be matched to healthy volunteers from a similar environment. Additionally, school age children admitted with severe asthma will be evaluated and breath samples will be collected. All participants will undergo breath sampling on admission and upon recovery, up to six months following discharge. A range of online technologies including: proton-transfer-reaction mass spectrometry (PTR-MS), gas chromatography ion mobility spectrometry (GC-IMS), atmospheric pressure chemical ionisation- mass spectrometry (APCI-MS) and offline technologies including gas chromatography mass spectroscopy (GC-MS) and comprehensive two-dimensional gas chromatography-mass spectrometry (GCxGC-MS) will be utilised for VOC discovery and replication. For offline technologies a standardised CE marked breath sampling device (ReCIVA®) will be used. All recruited participants will be characterised using existing blood biomarkers including C - reactive protein (CRP), brain derived natriuretic peptide (BNP), Troponin-I and blood eosinophil levels and further evaluated using a range of standardised questionnaires, lung function testing including hand held forced oscillation technique (FOT) and fractional exhaled nitric oxide (FeNO), sputum cell counts and echocardiography for heart failure and COPD patients. Additional samples will be collected for bio-banking including urine, serum, plasma and sputum supernatants and plugs.
- Conditions
- Asthma, COPD, Heart Failure, Community-acquired Pneumonia, Healthy, Breathlessness
- Keywords
- Acute Breathlessness, Breathomics
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Heart Failure, Community-Acquired Pneumonia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-6 months
Secondary outcomes (46)
Patient defined breathlessness
Participants are asked to provide information on their state of breathlessness
Measured: visit 1a (first visit), visit 2 (0-6 months)
COPD Assessment Test (CAT) (Questionnaire)
Evaluation and rehabilitation education guidance on the respiratory and motor functions of patients with chronic obstructive pulmonary disease. The CAT has a scoring range of 0-40, with Since COPD is a progressive disease, a fi xed target score for all patients cannot be set. In Practice, a target for improvement in individual patient CAT scores may be set, based on an holistic assessment of the patient. A change of 2 units suggests a meaningful difference. This test should be used in conjunction with the eMRC and forced expiratory volume in one second (FEV1) to determine COPD health assessment of participants.
Measured: visit 1a (first visit), visit 2 (0-6 months)
NASA task load index
Evaluation breath testing work load using mental, physical, temporal, performance, effort and frustration. Participants are asked to mark a scale based on how demanding the task was for each of the domains above.
Measured: visit 1a (first visit), visit 2 (0-6 months)
Asthma quality of life questionaire (AQLQ)
Evaluation quality of life in asthmatic patients based on their level of activity, symptoms, environment and emotion.
Measured: visit 1a (first visit), visit 2 (0-6 months)
Asthma control questionnaire (ACQ)
Measure of asthma control
Measured: visit 1a (first visit), visit 2 (0-6 months)
extended Medical Research Council (eMRC) Dyspnea Scale
Assessing respiratory breathlessness symptoms (Grade 0-5b, with Grade 0 being breathlessness with strenuous exercise to Grade 5b being breathlessness for daily activities like dressing).
Measured: visit 1a (first visit), visit 2 (0-6 months)
Visual analogue score (VAS) total and individual dyspnoea, cough and wheeze (100mm) scores
The participant is asked to place a mark (X) on the scale at the point that best describes their health currently. Minimum score 0mm (better outcome), maximum score 100mm (worse outcome) for each section of the scale (dyspnoea, cough, wheeze).
Measured: visit 1a (first visit), visit 2 (0-6 months)
NewYork Heart Association Dyspnoea score (NYHA)
Assessing grades of breathlessness specifically designed for heart failure patients
Measured: visit 1a (first visit), visit 2 (0-6 months)
Sputum collection for assessment of purulence, cytology and metagenomics
Participants are asked to provide a spontaneous sputum sample assessing purulence, cytology and metagenomics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Pre and post bronchodilator (BD) spirometry to assess lung function
To assess lung function
Measured: visit 1a (first visit), visit 2 (0-6 months)
fraction exhaled nitric oxide (FeNO) assessing airway inflammation
To assess airway inflammation in asthmatics. Patients are asked to blow into a mouthpiece for few seconds which detects the amount of exhaled nitric oxide.
Measured: visit 1a (first visit), visit 2 (0-6 months)
Hand held oscillometry assessing small airway lung function
To assess small airway lung function
Measured: visit 1a (first visit), visit 2 (0-6 months)
Quadriceps ultrasound measuring quadriceps size as a degree of frailty
To assess degree of frailty and muscle breakdown during hospital admission. Participants have their quadriceps muscle size measured using an ultrasound machine.
Measured: visit 1a (first visit)
Four meter gait
physical performance - measure of frailty
Measured: visit 1a (first visit), visit 2 (0-6 months)
Exacerbation history
participants are asked to provide information on recent exacerbations of airway disease
Measured: visit 1a (first visit), visit 2 (0-6 months)
DECAF score assessing in hospital mortality in COPD patients
DECAF score has a minimum score of 1 (better outcome) and a maximum score of 6(worse outcome) used for assessment of severity of COPD exacerbation measures eMRC score, Eosinopenia, consolidation, acidemia and atrial fibrillation
Measured: visit 1a (first visit)
CURB65 score assessing mortality in Pneumonia patients
CURB65 is used in assessment of 30 day mortality of Pneumonia based on confusion, urea, respiratory rate, blood pressure and age.Scores range from 1 (better outcome) to 5 (worse outcome)
Measured: visit 1a (first visit)
BTS asthma severity score
BTS asthma severity score is used in assessment of asthma severity based on peak flow, respiratory rate, oxygen levels, altered level of consciousness, arrythmia, hypotension, cyanosis, silent chest and respiratory effort. Patients are then classified into mild (better outcome), moderate, severe and life threatening (worse outcome).
Measured: visit 1a (first visit)
Meta analysis global group in chronic heart failure (MAGGIC - risk calculator)
Assessment of heart failure severity based on age, gender, diabetes, COPD, heart failure diagnosed in the last 18 months, current smoker, NYHA class, b blockers, ACEI or ARB, BMI, systolic BP, creatinine and ejection fraction
Measured: visit 1a (first visit)
Sputum differential Cell Count
Differential Cell Count to assess inflammation at exacerbation events.
Measured: visit 1a (first visit), visit 2 (0-6 months)
Breath volatile organic compound (VOC) profiling
Participants are asked to provide a breath sample to measure VOC using Compact Mass Spectrometer (CMS), Gas chromatography ion mobility spectrometer (GC-IMS), gas chromatography mass spectrometer (GC-MS), Proton transfer reaction time of flight mass spectrometer (PTR-Tof-MS), gas chromatography gas chromatography mass spectrometer (GCxGC-MS).
Measured: visit 1a (first visit), visit 2 (0-6 months)
Serum/Plasma Inflammatory Biomarkers
To assess systemic inflammation. Plasma/ serum biomarkers are exploratory and we do not have a specific list of biomarkers yet.
Measured: visit 1a (first visit), visit 2 (0-6 months)
Full blood count (FBC)
Blood Biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
C-reactive protein (CRP)
Blood Biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
Troponin-I
Blood Biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
B-type naturitic peptide (BNP)
Blood biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
RNA (PAXgene)
Blood Biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
DNA (PAXgene)
Blood Biochemistry
Measured: visit 1a (first visit), visit 2 (0-6 months)
Age
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Smoking status, calculated using pack years (no. of cigarettes smoked per day X no. of years smoked divided by 20
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
BMI in kg/m^2
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Gender
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Heart rate
Vital signs
Measured: visit 1a (first visit), visit 2 (0-6 months)
Blood pressure
Vital signs
Measured: visit 1a (first visit), visit 2 (0-6 months)
Oxygen saturations
Vital signs
Measured: visit 1a (first visit), visit 2 (0-6 months)
Temperature
Vital signs
Measured: visit 1a (first visit), visit 2 (0-6 months)
Medical history
medical history
Measured: visit 1a (first visit), visit 2 (0-6 months)
Current medications
Medical history
Measured: visit 1a (first visit), visit 2 (0-6 months)
Physical examination
Physical examination
Measured: visit 1a (first visit), visit 2 (0-6 months)
12 lead Electrocardiogram (ECG)
cardiac function
Measured: visit 1a (first visit), visit 2 (0-6 months)
Echocardiogram (ECHO)
cardiac function
Measured: visit 1a (first visit), visit 2 (0-6 months)
Chest Xray
Respiratory function
Measured: visit 1a
Height
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Weight
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Ethnicity
Demographics
Measured: visit 1a (first visit), visit 2 (0-6 months)
Review of adverse events and serious adverse events
Review of untoward medical occurrences
Measured: visit 1a (first visit), visit 2 (0-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start2 Feb 2017
- Primary completion30 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Engineering and Physical Sciences Research Council, UK, Loughborough University, University Hospitals, Leicester, Owlstone Ltd, B & S ANALYTIK GmbH, Advion Biosciences Ltd
- Responsible party
- Sponsor
- Investigators
- Salman Siddiqui, Professor, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672994
- Sponsor's protocol ID
- 0569
- Acronym
- EMBER
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2018
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30852546
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Metabolomic Biomarkers in the Acutely Breathless Patient
- ClinicalTrials.gov ID
- NCT03672994
- Acronym / sponsor ID
- EMBER / 0569
- Conditions
- Asthma, COPD, Heart Failure, Community-acquired Pneumonia, Healthy, Breathlessness
- Keywords
- Acute Breathlessness, Breathomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Medical Research Council, Engineering and Physical Sciences Research Council, UK, Loughborough University, University Hospitals, Leicester, Owlstone Ltd, B & S ANALYTIK GmbH, Advion Biosciences Ltd
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective real world observational study carried out across three acute admissions units. Participants with self-reported acute breathlessness, with a confirmed primary diagnosis of either acute heart failure, community acquired pneumonia and acute exacerbation of asthma or COPD will be recruited within 24 hours of admission. These will be matched to healthy volunteers from a similar environment. Additionally, school age children admitted with severe asthma will be evaluated and breath samples will be collected. All participants will undergo breath sampling on admission and upon recovery, up to six months following discharge. A range of online technologies including: proton-transfer-reaction mass spectrometry (PTR-MS), gas chromatography ion mobility spectrometry (GC-IMS), atmospheric pressure chemical ionisation- mass spectrometry (APCI-MS) and offline technologies including gas chromatography mass spectroscopy (GC-MS) and comprehensive two-dimensional gas chromatography-mass spectrometry (GCxGC-MS) will be utilised for VOC discovery and replication. For offline technologies a standardised CE marked breath sampling device (ReCIVA®) will be used. All recruited participants will be characterised using existing blood biomarkers including C - reactive protein (CRP), brain derived natriuretic peptide (BNP), Troponin-I and blood eosinophil levels and further evaluated using a range of standardised questionnaires, lung function testing including hand held forced oscillation technique (FOT) and fractional exhaled nitric oxide (FeNO), sputum cell counts and echocardiography for heart failure and COPD patients. Additional samples will be collected for bio-banking including urine, serum, plasma and sputum supernatants and plugs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- Capable (in the opinion of the EMBER clinical research investigator(s) of providing serial breath samples.
- 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.
- 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.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Key exclusion criteria (4 listed)
- Female participants who are known to be pregnant, lactating or planning pregnancy during the course of the study.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discovery of exhaled breath biomarkers
Time frame: 0-6 months
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)
46 secondary outcomes
Patient defined breathlessness
Time frame: visit 1a (first visit), visit 2 (0-6 months)
COPD Assessment Test (CAT) (Questionnaire)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
NASA task load index
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Asthma quality of life questionaire (AQLQ)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Asthma control questionnaire (ACQ)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
extended Medical Research Council (eMRC) Dyspnea Scale
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Visual analogue score (VAS) total and individual dyspnoea, cough and wheeze (100mm) scores
Time frame: visit 1a (first visit), visit 2 (0-6 months)
NewYork Heart Association Dyspnoea score (NYHA)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Sputum collection for assessment of purulence, cytology and metagenomics
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Pre and post bronchodilator (BD) spirometry to assess lung function
Time frame: visit 1a (first visit), visit 2 (0-6 months)
fraction exhaled nitric oxide (FeNO) assessing airway inflammation
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Hand held oscillometry assessing small airway lung function
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Quadriceps ultrasound measuring quadriceps size as a degree of frailty
Time frame: visit 1a (first visit)
Four meter gait
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Exacerbation history
Time frame: visit 1a (first visit), visit 2 (0-6 months)
DECAF score assessing in hospital mortality in COPD patients
Time frame: visit 1a (first visit)
CURB65 score assessing mortality in Pneumonia patients
Time frame: visit 1a (first visit)
BTS asthma severity score
Time frame: visit 1a (first visit)
Meta analysis global group in chronic heart failure (MAGGIC - risk calculator)
Time frame: visit 1a (first visit)
Sputum differential Cell Count
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Breath volatile organic compound (VOC) profiling
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Serum/Plasma Inflammatory Biomarkers
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Full blood count (FBC)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
C-reactive protein (CRP)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Troponin-I
Time frame: visit 1a (first visit), visit 2 (0-6 months)
B-type naturitic peptide (BNP)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
RNA (PAXgene)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
DNA (PAXgene)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Age
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Smoking status, calculated using pack years (no. of cigarettes smoked per day X no. of years smoked divided by 20
Time frame: visit 1a (first visit), visit 2 (0-6 months)
BMI in kg/m^2
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Gender
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Heart rate
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Blood pressure
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Oxygen saturations
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Temperature
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Medical history
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Current medications
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Physical examination
Time frame: visit 1a (first visit), visit 2 (0-6 months)
12 lead Electrocardiogram (ECG)
Time frame: visit 1a (first visit), visit 2 (0-6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 30852546Ibrahim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salman Siddiqui, Professor principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of exhaled breath biomarkers (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.