An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients

This is an interventional treatment trial for Airway Inflammation focused on measuring Airway inflammation, Anti-inflammatory reliever, SYMBICORT, Maintenance anti-inflammatory therapy, Reliever medication, Salbutamol Read More

Inclusion Criteria:

1. Provision of signed and dated, written Informed Consent Form (ICF) prior to any study-related procedures, sampling, and analyses (at Visit 1).
2. Patient must be ≥18 years of age at the time of signing the ICF.
3. A physician diagnosis of asthma for a minimum ≥6 months prior to Visit 1.
4. Use of ICS (low or medium dose)/LABA (GINA 2018 guidelines) for asthma for ≥3 months prior to Visit 1.
5. Episode of asthma symptom worsening requiring overuse of reliever (more than the standard for the individual patient) at least once during the last 30 days prior to Visit 1.
6. The patient must be able to read speak, and understand local language; and be able to, in the Investigator's judgment, comply with the study protocol.
7. Able to perform home FeNO and spirometry assessments and complete the asthma symptom diary on a regular basis during the conduct of the study.
8. Male and/or female
9. Negative pregnancy test (urine) for female patients of childbearing potential at Visit 1.

10. For randomisation at Visit 2, patients should fulfil the following criteria:

    1. Symptoms requiring reliever medication use for a minimum of 2 to a maximum 8 days out of the last 10 days of the Run-in Period.
    2. At least 80% overall compliance rate for performing FeNO and spirometry assessments and completing the asthma symptom diary during the Run-in Period.

Exclusion Criteria:

1. Any significant disease or disorder, or evidence of drug/substance abuse which in the Investigator's opinion would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the patient to participate in the study.
2. Any asthma worsening requiring change in asthma treatment other than the patient's prescribed reliever medication (SYMBICORT as Maintenance and Reliever Therapy [SMART] therapy, SABA, and/or short-acting anticholinergic agent) within 30 days prior to Visit 1.
3. Medical history of life- threatening asthma including intubation and intensive care unit admission.
4. Medical conditions (other than allergic rhinitis) or medications (other than ICS) that will influence FeNO, as judged by the Investigator.
5. Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension).
6. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained (Visit 1) or during the screening/Run-in Period.
7. A severe asthma exacerbation (defined by an exacerbation resulting in ≥3 days of oral corticosteroids [or one depot intramuscular injection of a glucocorticosteroid], an urgent care or emergency room visit that results in systemic corticosteroids, or an inpatient hospitalisation due to asthma) within 30 days prior to screening.
8. Any disease state or procedure that may necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
9. Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (patients that had localised carcinoma of the skin which was resected for cure will not be excluded).
10. Patients with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the patient.
11. Other concurrent medical conditions: patients who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
12. Current smokers: previous smokers are allowed to be included provided that they stopped smoking >12 months prior to Visit 1 AND have a smoking history of ≤10 pack-years.
13. Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
14. Participation in another clinical study with any marketed or investigational biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.
15. Participation in another clinical study with a non-biologic investigational product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1.
16. Patients with a known hypersensitivity to the study drugs or any of the excipients of the products.
17. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
18. Previous randomisation in the present study.
19. For women only: currently pregnant (confirmed with positive pregnancy test), breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the Investigator. Periodic abstinence, spermicides only, and the lactational amenorrhoea method are not acceptable methods of contraception.
20. Planned hospitalisation during the study that would interfere with study objectives as judged by the Investigator.