Asthma: Phenotyping EXacerbations

Asthma Clinical Trial

— APEX  

Official title:

Phenotyping Asthma Exacerbations: A Longitudinal Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293588
• Other study ID #: 19051
• Status: Recruiting
• Start date: November 22, 2019
• Est. completion date: July 2022

Study information

• Verified date: April 2021
• Source: University of Nottingham
• Contact: Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc
• Phone: 0115 823 1714
• Email: tim.harrison[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 exacerbation events in the sister APEX cohort.

Description:

This is a single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 200 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past year 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

INCLUSION

• Clinician diagnosed asthma.

• Male or female aged = 18 and = 85 years of age.

• One asthma exacerbation requiring additional treatment in the year 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.

EXCLUSION:

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Diagnostic Test:
• spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab
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

Locations

Country	Name	City	State
United Kingdom	Nottingham respriatory research unit	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of study participants with an eosinophilic and non eosinophhilic phenotype	Percentage of study participants with an eosinophilic and non eosinophhilic phenotype	3 years into the study
Secondary	The proportion of exacerbations associated with confrimed viral and bacterial infection	The prercentage of participabnts within the cohort with at least one exacerbation associated with confirmed viral and bacterial infection by the end of the study	3 years
Secondary	Asthma control questionnaire	ACQ score at baseline and then at exacerbation and annual visits. 0 is total control and 6 is severly uncontrolled	3 years
Secondary	Medication Adherence Rating Scale (MARS)	MARS at baseline and then at exacerbation and annual visits. 5 questions are propposed each with a score scale 1 to 5. A score of 1 having the best and 5 having the worst.	3 years
Secondary	Measuring Lung function and inflamamtion	Measure Forced Oscialltion Technique (FOT) and Spirometry and Fractional Exhaled Nitric Oxide (FENO) at baseline and then at exacerbation and anuual visits.	3 years
Secondary	Blood profile	Measure FBC CRP IgE at baseline. During an exacerbation and annual visit, FBC CRP will be measured. Additional blood will be taken at each visit for future research	3 years
Secondary	Nasal lavage fluid and throat swab	Nasal lavage will be preformed along side a throat swab to identify any virsuses at baseline, exacerbation and annual visits.	3 years
Secondary	Nasals brushes	Nasal bursh samples will be obtained to identify viral genetics at baseline, exacerbation and annual visits	3 years.
Secondary	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	3 years
Secondary	Induced sputum	Induced sputum will be attempted on all patients at baseline exacerbation and annual visit to assess sputum cell counts at each of the specific points.	3 years