ASTHMAAPEX 2NCT04293445
Asthma: Phenotyping Exacerbations 2
An observational study of ASTHMA, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The main outcomes of this study are to establish a cohort of well-phenotyped asthma patients with a recent history of an exacerbation. We aim to describe exacerbation profiles (phenotypes) of the cohort in terms of inflammatory/biomarker profile and bacterial/viral infection status and to compare these with… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ASTHMA
- What is being tested?
- spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2019to Jul 2022
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: A population of asthmatics who have had an exacerbation in the 60 months prior to the study
Who may be able to join
- Clinician diagnosed asthma.
- Male or female aged ≥ 18 and ≤ 85 years of age.
- One asthma exacerbation requiring additional treatment in 5 years prior to informed consent. This is defined as either: 3 or more consecutive day's treatment with oral corticosteroids; for participants not on maintenance steroids, OR at least a doubling of treatment with oral corticosteroids for 3 or more consecutive days, from a stable dose, for participants on maintenance therapy with oral corticosteroids. These can be patient-reported.
- On British Thoracic Society (BTS) step 1-5 treatment
- Current smokers can be included, provided there is good evidence of underlying asthma (for example, a life-long history of asthma, > 12% FEV1 reversibility or sputum or blood eosinophilia).
- Able (in the Investigator's opinion) and willing to comply, with all clinical investigation requirements.
- Non-English speaking participants should be proficient in their understanding of the English language, in order to be able to fully participate in the study.
Who cannot join
- Exacerbation in the 4 weeks prior to the Baseline visit. The use of biologic therapy, including Omalizumab, Mepolizumab or Benralizumab, at any time during the 3 months.
- prior to informed consent. Participants who commence biologic therapy during the course of the study will be withdrawn.
- A history more in keeping with smoking-related Chronic Obstructive Pulmonary Disease (COPD)
- Other clinically significant respiratory diseases.
- Use of regular high dose maintenance systemic corticosteroids (for example, a dose of > 10mgs of Prednisolone daily)
- Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigator, to impact on the ability to participate in the study or the study results.
- Pregnant women, lactating women or women who are planning to become pregnant.
- Participants with uncontrolled hypertension. Participation in a study involving an investigational medicinal product at any time during the 3 months prior to informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham respriatory research unit
Nottingham, Nottinghamshire, NG5 1PB
Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc, 0115 823 1714, tim.harrison@nottingham.ac.uk
Ashish Pradhan, MBBS, 0115 823 1695, ashish.pradhan@nottingham.ac.uk
About this study
Official title: Phenotyping Asthma Exacerbations: A Longitudinal Cohort Study 2
The main outcomes of this study are to establish a cohort of well-phenotyped asthma patients with a recent history of an exacerbation. We aim to describe exacerbation profiles (phenotypes) of the cohort in terms of inflammatory/biomarker profile and bacterial/viral infection status and to compare these with exacerbation events in the sister APEX cohort.
Read the detailed description
A single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 100 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past 5 years before informed consent. They will be identified from secondary care, primary care and the Nottingham Respiratory Research Database (NRRD).
After the Baseline visit, each subject will be followed for the duration of their participation in the study. Participants will be asked to contact the research team if they perceive that their asthma symptoms are worsening to the extent that they would usually seek help from a healthcare professional. They will then be invited to attend the Assessment Visit and potential Exacerbation Visit. Participants who complete this visit will then continue in the study, as we are interested in comparing subsequent events in the same individuals, to establish exacerbation stability and consistency.
All participants, whether they have attended an Assessment visit or not, will be invited to attend for an Annual visit. The research team will also contact participants at 3 monthly intervals, with their permission, to discuss the study and provide updates.
- Conditions
- ASTHMA
- Being tested
- spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab
- Keywords
- asthma exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swabDiagnostic test
At the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study participants with an eosinophilic and non eosinophhilic phenotype
Percentage of study participants with an eosinophilic and non eosinophhilic phenotype
Measured: 3 years
Secondary outcomes (9)
The proportion of exacerbations associated with confrimed viral and bacterial infection
The prercentage of participants within the cohort with at least one exacerbation associated with confirmed viral and bacterial infection by the end of the study
Measured: 3 years
Asthma control questionnaire
ACQ score at baseline and then at exacerbation and annual visits. 0 is total control and 6 is severely uncontrolled
Measured: 3 years
Medication Adherence Rating Scale (MARS)
MARS at baseline and then at exacerbation and annual visits. 5 Questions scored 1-5. 1 being the best and 5 being the worst.
Measured: 3 years
Measuring Lung function and inflammation
Measure Forced Oscialltion Technique (FOT) and Spirometry and Fractional Echaled Nitric Oxide (FENO) at baseline and then at exacerbation and annual visits.
Measured: 3 years
Blood profile
Measure FBC CRP IgE at baseline. During an exacerbation and Annual visit FBC CRP will be measured. Additional bloods will be taken at each visit for future research
Measured: 3 years
Nasal lavage fluid and throat swab
Nasal lavage will be performed along side a throat swab to identify any virsuses at baseline, exacerbation and annual visits.
Measured: 3 years
Skin Prick testing
Skin prick tests will be performed on all patients at baseline to assess if they are sensitive to common allergens and would be suggestive of atopy
Measured: 3 years.
Induced sputum
Induced sputum will be attempted on all patients at baseline exacerbation and on annual visits to assess sputum cell counts at each of the specific points.
Measured: 3 years
Nasal brushes
Nasal brush samples will be obtained to identify viral genetics at baseline, exacerbation and annual visits
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start22 Nov 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASTHMAStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293445
- Sponsor's protocol ID
- 19055
- Acronym
- APEX 2
- Status last verified
- Apr 2021
- First submitted
- 26 Nov 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Asthma Exacerbations: A Longitudinal Cohort Study 2
- ClinicalTrials.gov ID
- NCT04293445
- Acronym / sponsor ID
- APEX 2 / 19055
- Conditions
- ASTHMA
- Keywords
- asthma exacerbations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 3 Mar 2020 (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.
The main outcomes of this study are to establish a cohort of well-phenotyped asthma patients with a recent history of an exacerbation. We aim to describe exacerbation profiles (phenotypes) of the cohort in terms of inflammatory/biomarker profile and bacterial/viral infection status and to compare these with exacerbation events in the sister APEX cohort.
Detailed description
A single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 100 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past 5 years before informed consent. They will be identified from secondary care, primary care and the Nottingham Respiratory Research Database (NRRD).
After the Baseline visit, each subject will be followed for the duration of their participation in the study. Participants will be asked to contact the research team if they perceive that their asthma symptoms are worsening to the extent that they would usually seek help from a healthcare professional. They will then be invited to attend the Assessment Visit and potential Exacerbation Visit. Participants who complete this visit will then continue in the study, as we are interested in comparing subsequent events in the same individuals, to establish exacerbation stability and consistency.
All participants, whether they have attended an Assessment visit or not, will be invited to attend for an Annual visit. The research team will also contact participants at 3 monthly intervals, with their permission, to discuss the study and provide updates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A population of asthmatics who have had an exacerbation in the 60 months prior to the study
Key inclusion criteria (7 listed)
- Clinician diagnosed asthma.
- Male or female aged ≥ 18 and ≤ 85 years of age.
- One asthma exacerbation requiring additional treatment in 5 years prior to informed consent. This is defined as either: 3 or more consecutive day's treatment with oral corticosteroids; for participants not on maintenance steroids, OR at least a doubling of treatment with oral corticosteroids for 3 or more consecutive days, from a stable dose, for participants on maintenance therapy with oral corticosteroids. These can be patient-reported.
- On British Thoracic Society (BTS) step 1-5 treatment
- Current smokers can be included, provided there is good evidence of underlying asthma (for example, a life-long history of asthma, > 12% FEV1 reversibility or sputum or blood eosinophilia).
Key exclusion criteria (8 listed)
- Exacerbation in the 4 weeks prior to the Baseline visit. The use of biologic therapy, including Omalizumab, Mepolizumab or Benralizumab, at any time during the 3 months.
- prior to informed consent. Participants who commence biologic therapy during the course of the study will be withdrawn.
- A history more in keeping with smoking-related Chronic Obstructive Pulmonary Disease (COPD)
- Other clinically significant respiratory diseases.
- Use of regular high dose maintenance systemic corticosteroids (for example, a dose of > 10mgs of Prednisolone daily)
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, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swabAt the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation | Diagnostic test | – |
Primary outcome
Proportion of study participants with an eosinophilic and non eosinophhilic phenotype
Time frame: 3 years
Percentage of study participants with an eosinophilic and non eosinophhilic phenotype
9 secondary outcomes
The proportion of exacerbations associated with confrimed viral and bacterial infection
Time frame: 3 years
Asthma control questionnaire
Time frame: 3 years
Medication Adherence Rating Scale (MARS)
Time frame: 3 years
Measuring Lung function and inflammation
Time frame: 3 years
Blood profile
Time frame: 3 years
Nasal lavage fluid and throat swab
Time frame: 3 years
Skin Prick testing
Time frame: 3 years.
Induced sputum
Time frame: 3 years
Nasal brushes
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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.
Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc principal investigator
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, 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 7 inclusion and 8 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 29 Apr 2021. 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 Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc (0115 823 1714, tim.harrison@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of study participants with an eosinophilic and non eosinophhilic phenotype (time frame: 3 years). 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 29 Apr 2021; AzTrials last refreshed its copy on 2 Nov 2026.