Asthma AttackAPEX3NCT05446090
Asthma: Phenotyping Exacerbations 3
An observational study of Asthma Attack, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Attack
- What is being tested?
- Spirometry including peak flow, Fractional Exhaled Nitric Oxide (FeNO) and Forced Oscillation Technique (FOT)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital with suspected asthma attacks.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospital
Nottingham, Nottinghamshire, NG5 1PB
Elizabeth Dark, +44 115 969 1169 ext. 78001, Elizabeth.Dark@nuh.nhs.uk
About this study
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.
Read more
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.
Read the detailed description
Asthma is a common condition affecting 9.8 million people in the United Kingdom1. Asthma attacks cause nearly 1500 deaths per year in the UK2 and account for over 90,000 hospital admissions and 1800 intensive care admissions costing at least 1 billion pounds a year3.
Non-asthma conditions such as Vocal Cord Dysfunction4 and Dysfunctional Breathing Pattern5 can mimic severe asthma and lead to hospital admission and inappropriate asthma treatment with potentially harmful high dose corticosteroids. However, the proportion of patients admitted with these asthma mimics is unclear.
The use of biomarkers to guide treatment in stable asthma is now commonplace, but this prospect has not been fully explored in acute asthma attacks. Determining the type of inflammation underlying an attack can, however be tricky because many patients receive oral corticosteroid prior to, or soon after admission, which promptly and markedly affects the most accessible type 2 asthma (T2) biomarkers7, the blood eosinophil count. Measurement of another T2 biomarker, fractional exhaled nitric oxide (FENO), during an attack may prove a useful measure of ongoing T2 airway inflammation, but this strategy requires assessment.
Airway obstruction in asthma attacks is assessed and confirmed by measuring peak expiratory flow and/or forced expiratory volumes. These measures are effort-dependent and can, therefore, be unreliable and misleading if improperly performed. We aim to evaluate the potential feasibility and utility of alternative diagnostic methods of assessing airway obstruction and measuring T2 biomarkers to see if these allow the distinction between actual asthma attacks and asthma attack mimics and also if they can distinguish different types of asthma attacks.
The pattern of recovery following asthma attacks is also not fully understood. Studies have reported varying recovery times8 and inconsistencies in the response of airway obstruction9 and T2 biomarkers10 to corticosteroid treatment in acute asthma.
The investigators hypothesise that a significant proportion of patients admitted to hospital with suspected asthma attacks have an alternate cause for their clinical presentation. To further explore this, The investigators propose an observational study to describe and investigate the characteristics of patients admitted with suspected severe asthma. The investigators will assess the utility of point of care, non-invasive biomarker measurements in identifying pulmonary and extrapulmonary traits in patients hospitalised due to presumed asthma attack. A variety of study assessments will be performed at the baseline visit (exacerbation visit), and two follow up visits following hospital discharge. Results of study assessments obtained during each study visit will be compared and analysed. This is the first study to prospectively investigate acute asthma both during and following exacerbation episodes. This will allow a comprehensive understanding and description of pulmonary and extrapulmonary traits as well as the pattern of recovery following asthma attacks.
- Conditions
- Asthma Attack
- Being tested
- Spirometry including peak flow, Fractional Exhaled Nitric Oxide (FeNO), Forced Oscillation Technique (FOT), Sputum Induction, Bloods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry including peak flowDiagnostic 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.
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.
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.
Sputum InductionProcedure or surgery
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.
BloodsDiagnostic test
Blood will be collected for laboratory analysis, including Vitamin D, Haematology, WCC differential, C-Reactive protein.
Nasal lavageDiagnostic 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.
Throat swabDiagnostic test
A throat swab will be taken at the baseline (attack) visit for viral identification.
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.
Nasal absorptionDiagnostic 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.
Medical History, Demographic, and Concomitant MedicationsOther
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.
Sino-nasal Outcome TestOther
The incidence of upper airway symptoms will be assessed using Sino-nasal Outcome Test (SNOT).
Gastroesophageal Reflux Disease QuestionnaireOther
The incidence of Gastroesophageal Reflux Disease will be assessed using GERDQ questionnaire.
Pittsburgh Vocal Cord Dysfunction IndexOther
The incidence of vocal cord dysfunction will be assessed using Pittsburgh Vocal Cord Dysfunction (VCD) Index
Nijmegen Questionnaire.Other
The incidence of dysfunctional breathing will be assessed using Nijmegen dysfunctional questionnaire.
Hospital Anxiety and Depression ScaleOther
The incidence of anxiety and depression will be assessed using Hospital Anxiety and Depression Scale (HADS).
Compliance and adherenceOther
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.
Acute Asthma Quality of Life QuestionnaireOther
The impact of acute asthma on quality of life will be assessed using Acute Asthma Quality of Life Questionnaire at baseline and follow up.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Attack patients. | Patients admitted with Asthma Attacks. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 14 days
Assessment of evidence of infection: CRP.
Assessment of evidence of infection: CRP.
Measured: 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.
Measured: 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
Measured: baseline
Assessment of adherence to medications (MARS, prescription records, inhaler technique) for the assessment of behavioural attack traits.
Assessment of behavioural attack traits.
Measured: baseline
Assessment of airway obstruction at attack and recovery visits using peak expiratory flow rate (PEFR).
Assessment of airway obstruction
Measured: 14 days
Assessment of airway obstruction at attack and recovery visits using spirometry.
Assessment of airway obstruction
Measured: 14 days
Assessment of airway obstruction at attack and recovery visits using Forced Oscillation Technique (FOT).
Assessment of airway obstruction
Measured: 14 days
Assessment of airway obstruction at attack using physician recorded expiratory wheeze
Assessment of airway obstruction
Measured: baseline
Assessment of airway inflammation at attack and recovery visits using Fractional Exhaled Nitric Oxide (FeNO).
Assessment of airway inflammation
Measured: 14 days
Assessment of airway inflammation at attack and recovery visits using sputum inflammatory cell count.
Assessment of airway inflammation
Measured: 14 days
Assessment of airway inflammation at attack and recovery visits using blood eosinophil count.
Assessment of airway inflammation
Measured: 14 days
Assessment of symptom burden at attack and recovery visits using the Acute AQLQ questionnaire
Assessment of symptom burden
Measured: 28 days
Assessment of Body Mass Index BMI.
Assessment of Body Mass Index BMI.
Measured: 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).
Measured: baseline
The assessment of the incidence of Gastroesophageal Reflux Disease.
The assessment of the incidence of Gastroesophageal Reflux Disease using the GERDQ questionnaire.
Measured: 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.
Measured: baseline
The assessment of the incidence of dysfunctional breathing
The assessment of the incidence of dysfunctional breathing using the Nijmegen dysfunctional questionnaire.
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start9 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AttackStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Martin, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446090
- Sponsor's protocol ID
- 304615-21066
- Acronym
- APEX3
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plans yet.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma: Phenotyping Exacerbations 3
- ClinicalTrials.gov ID
- NCT05446090
- Acronym / sponsor ID
- APEX3 / 304615-21066
- Conditions
- Asthma Attack
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jul 2022 (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.
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.
Detailed description
Asthma is a common condition affecting 9.8 million people in the United Kingdom1. Asthma attacks cause nearly 1500 deaths per year in the UK2 and account for over 90,000 hospital admissions and 1800 intensive care admissions costing at least 1 billion pounds a year3.
Non-asthma conditions such as Vocal Cord Dysfunction4 and Dysfunctional Breathing Pattern5 can mimic severe asthma and lead to hospital admission and inappropriate asthma treatment with potentially harmful high dose corticosteroids. However, the proportion of patients admitted with these asthma mimics is unclear.
The use of biomarkers to guide treatment in stable asthma is now commonplace, but this prospect has not been fully explored in acute asthma attacks. Determining the type of inflammation underlying an attack can, however be tricky because many patients receive oral corticosteroid prior to, or soon after admission, which promptly and markedly affects the most accessible type 2 asthma (T2) biomarkers7, the blood eosinophil count. Measurement of another T2 biomarker, fractional exhaled nitric oxide (FENO), during an attack may prove a useful measure of ongoing T2 airway inflammation, but this strategy requires assessment.
Airway obstruction in asthma attacks is assessed and confirmed by measuring peak expiratory flow and/or forced expiratory volumes. These measures are effort-dependent and can, therefore, be unreliable and misleading if improperly performed. We aim to evaluate the potential feasibility and utility of alternative diagnostic methods of assessing airway obstruction and measuring T2 biomarkers to see if these allow the distinction between actual asthma attacks and asthma attack mimics and also if they can distinguish different types of asthma attacks.
The pattern of recovery following asthma attacks is also not fully understood. Studies have reported varying recovery times8 and inconsistencies in the response of airway obstruction9 and T2 biomarkers10 to corticosteroid treatment in acute asthma.
The investigators hypothesise that a significant proportion of patients admitted to hospital with suspected asthma attacks have an alternate cause for their clinical presentation. To further explore this, The investigators propose an observational study to describe and investigate the characteristics of patients admitted with suspected severe asthma. The investigators will assess the utility of point of care, non-invasive biomarker measurements in identifying pulmonary and extrapulmonary traits in patients hospitalised due to presumed asthma attack. A variety of study assessments will be performed at the baseline visit (exacerbation visit), and two follow up visits following hospital discharge. Results of study assessments obtained during each study visit will be compared and analysed. This is the first study to prospectively investigate acute asthma both during and following exacerbation episodes. This will allow a comprehensive understanding and description of pulmonary and extrapulmonary traits as well as the pattern of recovery following asthma attacks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Attack patients. | – | 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 QuestionnairePatients admitted with Asthma Attacks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital with suspected asthma attacks.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry including peak flowSpirometry 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 | Asthma Attack patients. |
| 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 | Asthma Attack patients. |
| 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. | Diagnostic test | Asthma Attack patients. |
| Sputum InductionSputum 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. | Procedure or surgery | Asthma Attack patients. |
| BloodsBlood will be collected for laboratory analysis, including Vitamin D, Haematology, WCC differential, C-Reactive protein. | Diagnostic test | Asthma Attack patients. |
| Nasal lavageNasal 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 | Asthma Attack patients. |
| Throat swabA throat swab will be taken at the baseline (attack) visit for viral identification. | Diagnostic test | Asthma Attack patients. |
| 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 | Asthma Attack patients. |
| Nasal absorptionNasal absorption will be used to collect mucosal lining fluid from the respiratory tract for cytokines profiling at baseline (attack) and at second visits. | Diagnostic test | Asthma Attack patients. |
| Medical History, Demographic, and Concomitant MedicationsMedical 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 | Asthma Attack patients. |
| Sino-nasal Outcome TestThe incidence of upper airway symptoms will be assessed using Sino-nasal Outcome Test (SNOT). | Other | Asthma Attack patients. |
| Gastroesophageal Reflux Disease QuestionnaireThe incidence of Gastroesophageal Reflux Disease will be assessed using GERDQ questionnaire. | Other | Asthma Attack patients. |
| Pittsburgh Vocal Cord Dysfunction IndexThe incidence of vocal cord dysfunction will be assessed using Pittsburgh Vocal Cord Dysfunction (VCD) Index | Other | Asthma Attack patients. |
| Nijmegen Questionnaire.The incidence of dysfunctional breathing will be assessed using Nijmegen dysfunctional questionnaire. | Other | Asthma Attack patients. |
| Hospital Anxiety and Depression ScaleThe incidence of anxiety and depression will be assessed using Hospital Anxiety and Depression Scale (HADS). | Other | Asthma Attack patients. |
| Compliance and adherenceIn 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 | Asthma Attack patients. |
| Acute Asthma Quality of Life QuestionnaireThe impact of acute asthma on quality of life will be assessed using Acute Asthma Quality of Life Questionnaire at baseline and follow up. | Other | Asthma Attack patients. |
Primary outcome
Assessment of cytokine levels in nasal lining fluid at attack and recovery visits
Time frame: 14 days
Nasal absorption will be used to collect mucosal lining fluid from the respiratory tract for cytokines profiling at baseline (attack) and at second visits.
The measurement of vitamin D levels in the blood on admission to the hospital
Time frame: baseline
vitamin D levels in the blood on admission to the hospital
Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC&S).
Time frame: 14 days
Assessment of evidence of infection: sputum for bacterial culture and sensitivity (MC\&S).
Assessment of evidence of infection: CRP.
Time frame: 14 days
Assessment of evidence of infection: CRP.
Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.
Time frame: baseline
Assessment of evidence of infection: Throat swab/nasal lavage for viral PCR.
A specific asthma history (polypharmacy, previous asthma attacks, triggers, Personalised Asthma Action Plan) for the assessment of risk factor for attack.
Time frame: baseline
Assessment of risk factor for attack
Assessment of adherence to medications (MARS, prescription records, inhaler technique) for the assessment of behavioural attack traits.
Time frame: baseline
Assessment of behavioural attack traits.
Assessment of airway obstruction at attack and recovery visits using peak expiratory flow rate (PEFR).
Time frame: 14 days
Assessment of airway obstruction
Assessment of airway obstruction at attack and recovery visits using spirometry.
Time frame: 14 days
Assessment of airway obstruction
Assessment of airway obstruction at attack and recovery visits using Forced Oscillation Technique (FOT).
Time frame: 14 days
Assessment of airway obstruction
Assessment of airway obstruction at attack using physician recorded expiratory wheeze
Time frame: baseline
Assessment of airway obstruction
Assessment of airway inflammation at attack and recovery visits using Fractional Exhaled Nitric Oxide (FeNO).
Time frame: 14 days
Assessment of airway inflammation
Assessment of airway inflammation at attack and recovery visits using sputum inflammatory cell count.
Time frame: 14 days
Assessment of airway inflammation
Assessment of airway inflammation at attack and recovery visits using blood eosinophil count.
Time frame: 14 days
Assessment of airway inflammation
Assessment of symptom burden at attack and recovery visits using the Acute AQLQ questionnaire
Time frame: 28 days
Assessment of symptom burden
Assessment of Body Mass Index BMI.
Time frame: baseline
Assessment of Body Mass Index BMI.
Assessment of the incidence of upper airway symptoms.
Time frame: baseline
The incidence of upper airway symptoms will be assessed using the Sino-nasal Outcome Test (SNOT).
The assessment of the incidence of Gastroesophageal Reflux Disease.
Time frame: baseline
The assessment of the incidence of Gastroesophageal Reflux Disease using the GERDQ questionnaire.
The assessment of the incidence of vocal cord dysfunction
Time frame: baseline
The assessment of the incidence of vocal cord dysfunction using the Pittsburgh Vocal Cord Dysfunction (VCD) Index.
The assessment of the incidence of dysfunctional breathing
Time frame: baseline
The assessment of the incidence of dysfunctional breathing using the Nijmegen dysfunctional questionnaire.
The assessment of the incidence of anxiety and depression
Time frame: baseline
The assessment of the incidence of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided. No plans yet.
Related trials for Asthma Attack
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingPhase 2
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
Asthma Acute, Asthma Attack
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
Active, not recruiting
Scaling up the Integrated Care Pathway for Acute Asthma to All Osakidetza Pediatric Services Through a Cluster-randomized SMART Design
Asthma in Children
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
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.
Matthew Martin principal investigator
The University of Nottingham
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 Attack, run by University of Nottingham 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mouaid Aljehani (+44 115 969 1169 ext. 78014, Mouaid.Aljehani@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cytokine levels in nasal lining fluid at attack and recovery visits (time frame: 14 days). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2022.