Study of Hospitalised Patients With Acute Respiratory Conditions

NCT05095090 | Unknown

• 1 other identifier: 0822
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aim to characterise patients admitted to hospital with an acute respiratory condition, or acute worsening of their chronic lung condition. This will enable identification of predictors of future risk, as well as develop potential interventions targets.

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

Outcome Measures

Primary Outcomes (3)

• 30 days hospital re-admission rate

  To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent

  30 days

• Length of index hospital admission stay

  To calculate the length of the index hospital stay

  Variable (up to 52 weeks)

• 30 days mortality rate

  To calculate the percentage of mortality within 30 days from consent

  30 days

Secondary Outcomes (3)

• Total number of hospital readmission due to same underlying chronic lung disease.

  52 weeks

• Total number of non-hospitalised exacerbations of underlying chronic lung disease

  52 weeks

• Time from consent to death (respiratory causes and all causes)

  52 weeks

Other Outcomes (2)

• Assessment of breathlessness using eMRC dyspnoea scale

  52 weeks

• Assessment of quality of Life/symptoms using St. George's Respiratory Questionnaire (SGRQ)

  52 weeks

Study Arms (2)

Hospitalised Patients

Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease.

Matched Controls

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease. The study will include matched controls (non-hospitalised patients with stable chronic respiratory conditions or healthy volunteers). Co-participation in other ethically approved studies including interventional trials is permissible.

You may qualify if:

• Hospital admission with an acute respiratory diagnosis
• 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

You may not qualify if:

• 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
• Matched Controls
• Aged 18 years or above
• Patients with stable chronic respiratory conditions or healthy volunteers
• Able (in the Investigators opinion) \& willing to comply with all study requirements
• 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

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

As part of the optional blood tests specified above, specific samples can be analysed for genetic testing related to respiratory conditions. The participants will decide when signing the consent form, if they are happy for their samples to undergo genetic analysis. The results will not be communicated back to the participants.

MeSH Terms

Conditions

Asthma; Pneumonia; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Pulmonary Embolism; Pleural Diseases; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Neil Greening, PhD, MRCP

  NIHR Respiratory Biomedical Research Centre, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 27, 2021
• Study Start: February 2, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)