Acute Respiratory DiseaseCHESTYNCT05095090
Study of Hospitalised Patients With Acute Respiratory Conditions
An observational study of Acute Respiratory Disease and COPD Exacerbation Acute, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Disease, COPD Exacerbation Acute, Asthma
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2022to 30 Oct 2033
- Phase
- Observational
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include adults admitted to hospital with an acute respiratory condition, including exacerbations of an underlying physician-diagnosed chronic respiratory disease, as well as non-hospitalised patients under respiratory outpatient follow-up for a chronic respiratory condition. The study will also include healthy volunteers without chronic respiratory disease as a comparator group. Co-participation in other ethically approved studies, including interventional trials, is permitted.
Who may be able to join
- Hospital admission with an acute respiratory diagnosis, or currently under the care of hospital respiratory outpatient services for a chronic respiratory disease
- Participant is willing \& able to give informed consent for participation in the study
- Aged 18 years or above
- Able (in the Investigators opinion) \& willing to comply with all study requirements
- Aged 18 years or above
- No underlying respiratory disease as self-reported
- Able (in the Investigators opinion) \& willing to comply with all study requirements
Who cannot join
- Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina during current admission.
- 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.
- Known pregnancy
- Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent
- 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.
- Known pregnancy
- Additional inclusion and exclusion criteria for CHESTY sub-studies are detailed in the corresponding sub-study protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hamish McAuley, MBBS, MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital
Leicester, LE3 9QP
About this study
Official title: Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions
The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and mortality. A group of people with chronic respiratory disease who are being followed in respiratory outpatient clinics and a healthy control group without lung disease will also take part.
The main questions it aims to answer are:
Read more
- Which clinical, physical, functional, and biological characteristics are associated with short-term outcomes after hospitalisation, including 30-day hospital readmission, length of hospital stay, and 30-day mortality?
- Which characteristics are associated with longer-term recovery, future exacerbations, hospital readmissions, healthcare use, and mortality?
- Can measurements taken during or around the time of hospitalisation be used to identify people at greater risk of poor outcomes who may benefit from targeted interventions?
Participants will undergo clinical assessments that may include questionnaires, measurements of physical function and muscle strength, lung function tests, physical activity monitoring, and collection of biological samples. Some participants may also undergo additional assessments of body composition, muscle size and function, imaging, or muscle metabolism, including through nested sub-studies. Participants will be followed for up to 36 months to assess recovery and longer-term clinical outcomes.
Read the detailed description
The study will recruit adults who are either admitted to hospital with an acute respiratory condition or are under the care of hospital respiratory outpatient services for a chronic respiratory disease. Acute respiratory presentations may include exacerbations of chronic lung diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis and pleural disease, as well as acute respiratory illnesses including pneumonia, respiratory infection and pulmonary embolism. A separate healthy control group without underlying respiratory disease will also be recruited for comparison of selected exploratory measures.
Participants may be recruited during hospital admission or through respiratory outpatient services. Baseline assessments will be completed during hospitalisation or within 90 days of a routine clinical follow-up appointment, depending on the route of recruitment.
Participants recruited during an acute hospital admission may be invited to complete an early post-discharge assessment at approximately 30 days and up to three additional optional follow-up visits during the 12 months after discharge to assess clinical recovery. Participants recruited through respiratory outpatient services will be invited to undergo annual follow-up assessments. Follow-up for the main cohort will continue for up to 36 months, with permitted visit windows of up to 90 days.
Follow-up assessments may be completed by telephone, during a face-to-face research visit at the Biomedical Research Centre, during a research visit for another ethically approved study, or alongside routine clinical follow-up. Participants may choose not to attend further study visits after recruitment without affecting their usual clinical care.
If a participant is admitted to hospital during study follow-up, they may be invited to complete an additional assessment during the acute admission, within 7 days of hospitalisation, followed by up to three further assessments during the subsequent 12 months. Healthcare utilisation and clinical outcome data, including subsequent hospital admissions and treatments, may also be collected remotely from primary and secondary healthcare records.
Study assessments may include clinical characteristics, symptoms, health-related quality of life, frailty, sarcopenia, physical function, muscle strength, lung function, physical activity, body composition, muscle structure and function, physiological measurements, imaging and biological samples. These data will be used to characterise recovery following acute respiratory illness, investigate hospital-associated disability, explore potential biomarkers and develop approaches to risk stratification.
Healthy controls will undergo a baseline assessment only and will provide comparator data for selected exploratory outcomes.
MPES SUB-STUDY:
The Muscle Phenotyping Exploratory Study (MPES) is a sub-study nested within CHESTY and will be conducted at Glenfield Hospital. It is designed to provide more detailed assessment of skeletal muscle structure, function and metabolism using methods that complement the broader clinical phenotyping undertaken in the main CHESTY cohort.
The sub-study has two main aims. First, it will assess the feasibility, safety and tolerability of the additional muscle phenotyping methods, including high-density surface electromyography (EMG), ingested stable isotope tracer methodology and muscle biopsy procedures, in participants with respiratory disease and healthy volunteers. Second, it will use these methods exploratorily to undertake detailed skeletal muscle phenotyping, including assessment of muscle activation and neuromuscular function, skeletal muscle mass, muscle protein synthesis and muscle protein breakdown.
Up to 20 participants will be recruited to each of three groups: patients hospitalised with an acute exacerbation of COPD, patients with stable COPD, and age-comparable control participants without chronic respiratory disease. Participants may be recruited from existing CHESTY participants who have provided appropriate consent or through the same screening and recruitment pathways used for the main CHESTY study.
The MPES sub-study will use the same study site, research team and core assessments as CHESTY, including measures of physical function and muscle strength, questionnaires and muscle biopsy procedures where applicable.
- Conditions
- Acute Respiratory Disease, COPD Exacerbation Acute, Asthma, Pneumonia
- Keywords
- Asthma, COPD (Chronic Obstructive Pulmonary Disease), Pneumonia, ILD (Interstitial Lung Diseases), Pulmonary Embolism, Pleural Diseases, Bronchiectasis
- Medical subject headings
- Asthma, Pneumonia, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pulmonary Embolism, Pleural Diseases, Bronchiectasis
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 |
|---|---|---|
| Hospitalised Patients | Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease. | |
| Matched Controls (stable COPD and healthy volunteers) | The study will include matched controls (non-hospitalised patients with stable chronic respiratory conditions or healthy volunteers) to compare the exploratory endpoints. The number of the matched controls will not exceed 25% of the main study recruitment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days hospital re-admission rate
To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent
Measured: 30 days
Length of index hospital admission stay
To calculate the length of the index hospital stay
Measured: Variable (up to 52 weeks)
30 days mortality rate
To calculate the percentage of mortality within 30 days from consent
Measured: 30 days
Secondary outcomes (3)
Total number of hospital readmission due to same underlying chronic lung disease.
To evaluate the number of hospital readmission episodes due to same underlying chronic lung disease over a 52 weeks period.
Measured: 52 weeks
Total number of non-hospitalised exacerbations of underlying chronic lung disease
To evaluate the number of non-hospitalised exacerbations of chronic lung disease e.g. asthma, Chronic Obstructive Pulmonary Diseases (COPD), etc. over 52 weeks
Measured: 52 weeks
Time from consent to death (respiratory causes and all causes)
To measure the time from consent to death within 52 weeks from consent. This will include both respiratory and all causes of mortality
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start2 Feb 2022
- Primary completion31 Oct 2029 (estimated)
- Study completion30 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Neil Greening, PhD, MRCP, Principal investigator, NIHR Respiratory Biomedical Research Centre, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095090
- Sponsor's protocol ID
- 0822
- Acronym
- CHESTY
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No