Asthma: Phenotyping Exacerbations 3

NCT05446090 | Unknown DMC FDA Device

• 1 other identifier: 304615-21066
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (21)

• Assessment of cytokine levels in nasal lining fluid at attack and recovery visits

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

  14 days

• The measurement of vitamin D levels in the blood on admission to the hospital

  vitamin D levels in the blood on admission to the hospital

  baseline

• Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC&S).

  Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC\&S).

  14 days

• Assessment of evidence of infection: CRP.

  Assessment of evidence of infection: CRP.

  14 days

• Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.

  Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.

  baseline

• A specific asthma history (polypharmacy, previous asthma attacks, triggers, Personalised Asthma Action Plan) for the assessment of risk factor for attack.

  Assessment of risk factor for attack

  baseline

• Assessment of adherence to medications (MARS, prescription records, inhaler technique) for the assessment of behavioural attack traits.

  Assessment of behavioural attack traits.

  baseline

• Assessment of airway obstruction at attack and recovery visits using peak expiratory flow rate (PEFR).

  Assessment of airway obstruction

  14 days

• Assessment of airway obstruction at attack and recovery visits using spirometry.

  Assessment of airway obstruction

  14 days

• Assessment of airway obstruction at attack and recovery visits using Forced Oscillation Technique (FOT).

  Assessment of airway obstruction

  14 days

• Assessment of airway obstruction at attack using physician recorded expiratory wheeze

  Assessment of airway obstruction

  baseline

• Assessment of airway inflammation at attack and recovery visits using Fractional Exhaled Nitric Oxide (FeNO).

  Assessment of airway inflammation

  14 days

• Assessment of airway inflammation at attack and recovery visits using sputum inflammatory cell count.

  Assessment of airway inflammation

  14 days

• Assessment of airway inflammation at attack and recovery visits using blood eosinophil count.

  Assessment of airway inflammation

  14 days

• Assessment of symptom burden at attack and recovery visits using the Acute AQLQ questionnaire

  Assessment of symptom burden

  28 days

• Assessment of Body Mass Index BMI.

  Assessment of Body Mass Index BMI.

  baseline

• Assessment of the incidence of upper airway symptoms.

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

  baseline

• The assessment of the incidence of Gastroesophageal Reflux Disease.

  The assessment of the incidence of Gastroesophageal Reflux Disease using the GERDQ questionnaire.

  baseline

• The assessment of the incidence of vocal cord dysfunction

  The assessment of the incidence of vocal cord dysfunction using the Pittsburgh Vocal Cord Dysfunction (VCD) Index.

  baseline

• The assessment of the incidence of dysfunctional breathing

  The assessment of the incidence of dysfunctional breathing using the Nijmegen dysfunctional questionnaire.

  baseline

• The assessment of the incidence of anxiety and depression

  The assessment of the incidence of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).

  baseline

Study Arms (1)

Asthma Attack patients.

Patients admitted with Asthma Attacks.

Diagnostic Test: Spirometry including peak flow; Diagnostic Test: Fractional Exhaled Nitric Oxide (FeNO); Diagnostic Test: Forced Oscillation Technique (FOT); Procedure: Sputum Induction; Diagnostic Test: Bloods; Diagnostic Test: Nasal lavage; Diagnostic Test: Throat swab; Diagnostic Test: Nasal Brush.; Diagnostic Test: Nasal absorption; Other: Medical History, Demographic, and Concomitant Medications; Other: Sino-nasal Outcome Test; Other: Gastroesophageal Reflux Disease Questionnaire; Other: Pittsburgh Vocal Cord Dysfunction Index; Other: Nijmegen Questionnaire.; Other: Hospital Anxiety and Depression Scale; Other: Compliance and adherence; Other: Acute Asthma Quality of Life Questionnaire

Interventions

Spirometry including peak flow DIAGNOSTIC_TEST

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.

Asthma Attack patients.

Fractional Exhaled Nitric Oxide (FeNO) DIAGNOSTIC_TEST

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.

Asthma Attack patients.

Forced Oscillation Technique (FOT) DIAGNOSTIC_TEST

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.

Asthma Attack patients.

Sputum Induction PROCEDURE

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.

Asthma Attack patients.

Bloods DIAGNOSTIC_TEST

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

Asthma Attack patients.

Nasal lavage DIAGNOSTIC_TEST

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.

Asthma Attack patients.

Throat swab DIAGNOSTIC_TEST

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

Asthma Attack patients.

Nasal Brush. DIAGNOSTIC_TEST

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.

Asthma Attack patients.

Nasal absorption DIAGNOSTIC_TEST

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

Asthma Attack patients.

Medical History, Demographic, and Concomitant Medications OTHER

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.

Asthma Attack patients.

Sino-nasal Outcome Test OTHER

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

Asthma Attack patients.

Gastroesophageal Reflux Disease Questionnaire OTHER

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

Asthma Attack patients.

Pittsburgh Vocal Cord Dysfunction Index OTHER

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

Asthma Attack patients.

Nijmegen Questionnaire. OTHER

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

Asthma Attack patients.

Hospital Anxiety and Depression Scale OTHER

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

Asthma Attack patients.

Compliance and adherence OTHER

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.

Asthma Attack patients.

Acute Asthma Quality of Life Questionnaire OTHER

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

Asthma Attack patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with suspected asthma attacks.

You may qualify if:

• The ability to give fully informed consent
• Male or female aged ≥ 18 years of age.
• Admission with a suspected acute asthma attack.
• Able (in the investigator's opinion) and willing to comply with clinical investigation requirements.

You may not qualify if:

• Other clinically significant respiratory diseases including predominant Chronic Obstructive Pulmonary Disease (COPD) and bronchiectasis.
• Any other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the investigator's opinion, to impact the ability to participate in the study or the study results.
• Pregnant women, lactating women or women who are planning to become pregnant.
• Investigator determined apparent other cause for admission.
• Acute COVID infection.
• Non-English-speaking participants who are unable to comprehend the reasons for the study due to limitations in understanding the English language

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham University Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and sputum samples.

MeSH Terms

Interventions

Fractional Exhaled Nitric Oxide Testing; Nasal Absorption; Health Records, Personal; Demography; Sino-Nasal Outcome Test; 4-amino-4'-hydroxylaminodiphenylsulfone; Compliance

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Tract Absorption; Absorption, Physiological; Absorption; Metabolism; Pharmacokinetics; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Patient Reported Outcome Measures; Health Care Surveys; Surveys and Questionnaires; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Elasticity; Mechanical Phenomena; Physical Phenomena

Study Officials

• Matthew Martin

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mouaid Aljehani

CONTACT

+44 115 969 1169; Mouaid.Aljehani@nottingham.ac.uk

Elizabeth Dark

CONTACT

+44 115 969 1169; Elizabeth.Dark@nuh.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: July 6, 2022
• Study Start: May 9, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

GB (1)