Asthma: Phenotyping Exacerbations 3

Summary

Exacerbations of asthma (asthma attacks) are very common in the UK. They are frightening for patients, expensive for the health service, and occasionally lead to avoidable deaths.

Despite the obvious importance of asthma attacks, they remain poorly understood. Although some of the triggers for attacks are known, the resultant characteristics of attacks are not. Recent research has shown different inflammation profiles associated with asthma attacks; however, this is not well understood, and all asthma attacks are treated the same. Increased knowledge about the nature of asthma attacks may better define these attacks and help develop more targeted treatment options.

This study aims to describe the characteristics of patients admitted with asthma attacks. The recovery and response to standard treatment for asthma attacks following discharge from the hospital will also be described.

This is achieved by studying the characteristics of asthma attacks in patients hospitalized with acute asthma. Participants will be asked to attend two follow-up visits during which their response to treatment will be described.

The study is planned to last for 2.5 years, with a recruitment period of 18 months, and will include 100 participants with acute asthma.

Conditions

• Asthma Attack

Interventions

DIAGNOSTIC_TEST

Spirometry including peak flow

Spirometry including peak flow to assess the degree of airway obstruction. Spirometry will be conducted according to a study SOP. The Global Lung Function (GLI) 2012 equations will be used. Reversibility testing will not be routinely performed. Thus, asthma medications will not normally be withheld for study visits and patients should take their inhalers as usual. The same type of device will be used at each visit.

DIAGNOSTIC_TEST

Fractional Exhaled Nitric Oxide (FeNO)

Fractional Exhaled Nitric Oxide (FeNO) to assess the degree of airway inflammation. FeNO will be measured using a standard device (NIOXX Vero®) in accordance with the manufacturer's guidelines. The same type of device will be used at each visit. FeNO should be performed prior to any other respiratory assessment if possible.

DIAGNOSTIC_TEST

Forced Oscillation Technique (FOT)

FOT is a non-invasive method that evaluates resistance and reactance in the respiratory system during tidal breathing. It should be performed after FeNO, but prior to Spirometry and will be conducted according to a study SOP.

PROCEDURE

Sputum Induction

Sputum Induction for the assessment of airway inflammation and microbiology. Sputum induction will be performed according to an SOP, which includes measures to protect the safety of participants. These consist of pre-treatment with Salbutamol, a short acting bronchodilator, stipulated levels of lung function in order to perform the test and stopping criteria. If the participant is unable to undergo the procedure, due to safety reasons, they will be asked to produce a spontaneous sputum sample. Sputum samples will be collected for a differential cell count, bacterial culture and sensitivity and storage for future research. Procedures for sampling and processing will be detailed in a study SOP.

DIAGNOSTIC_TEST

Bloods

Blood will be collected for laboratory analysis, including Vitamin D, Haematology, WCC differential, C-Reactive protein.

DIAGNOSTIC_TEST

Nasal lavage

Nasal lavage samples will be taken at the baseline (attack) visit. Samples will be obtained by injecting 5ml of sterile normal saline into the participant's nostrils via a nasal adaptor and then immediately aspirated. These will be placed in a sterile container and transported to the laboratory for viral identification. This procedure will be detailed in a study SOP.

DIAGNOSTIC_TEST

Throat swab

A throat swab will be taken at the baseline (attack) visit for viral identification.

DIAGNOSTIC_TEST

Nasal Brush.

Nasal brushings samples may be taken at baseline (attack) and at second visits for RNA and DNA extraction. This will be optional and specific consent from participants will be sought. Procedures for sampling and processing will be detailed in a study SOP.

DIAGNOSTIC_TEST

Nasal absorption

Nasal absorption will be used to collect mucosal lining fluid from the respiratory tract for cytokines profiling at baseline (attack) and at second visits.

OTHER

Medical History, Demographic, and Concomitant Medications

Medical history will include clinically significant diseases and prior surgeries and smoking history. A specific respiratory history will also be recorded. Demographic data will include age, sex and self- reported race/ethnicity. Medication use will also be collected.

OTHER

Sino-nasal Outcome Test

The incidence of upper airway symptoms will be assessed using Sino-nasal Outcome Test (SNOT).

OTHER

Gastroesophageal Reflux Disease Questionnaire

The incidence of Gastroesophageal Reflux Disease will be assessed using GERDQ questionnaire.

OTHER

Pittsburgh Vocal Cord Dysfunction Index

The incidence of vocal cord dysfunction will be assessed using Pittsburgh Vocal Cord Dysfunction (VCD) Index

OTHER

Nijmegen Questionnaire.

The incidence of dysfunctional breathing will be assessed using Nijmegen dysfunctional questionnaire.

OTHER

Hospital Anxiety and Depression Scale

The incidence of anxiety and depression will be assessed using Hospital Anxiety and Depression Scale (HADS).

OTHER

Compliance and adherence

In order to assess adherence as a factor in exacerbations, a participant's beliefs and attitudes towards medicines will be explored using the Medicines Adherence Report Scale (MARS) questionnaire. Non-intentional non-compliance with usual treatment will be assessed by checking inhaler technique; poor inhaler technique will be reported to the participant's clinical team. Also, GP records will be reviewed for information on medications prescribed in the last 12 months.

OTHER

Acute Asthma Quality of Life Questionnaire

The impact of acute asthma on quality of life will be assessed using Acute Asthma Quality of Life Questionnaire at baseline and follow up.

Sponsors & Collaborators

• University of Nottingham

  lead OTHER

Principal Investigators

• Matthew Martin · The University of Nottingham

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-09

Primary Completion

2023-12-31

Completion

2023-12-31

FDA Device

Yes

Countries

• United Kingdom

Study Locations