Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Symbicort® Turbohaler®
Product Name: Symbicort® Turbohaler® 100 micrograms/6 micrograms/inhalation
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-
Sponsors
Astra Zeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated, written 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 judgement, 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. Asthma exacerbation history: patient reported history of one (or more) severe asthma exacerbation requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral) in the 12 months prior to Visit 1. 9. Male and/or female 10. Negative pregnancy test (urine) for female patients of childbearing potential at Visit 1. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical conditions 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 (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), breastfeeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the Investigator. Periodic abstinence, spermicides only,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Descriptively characterise the relationship between inflammation, asthma symptoms, lung function, and reliever use measured daily over 24 weeks of treatment in the 2 treatment arms.;Secondary Objective: Descriptively characterise the inflammatory, asthma symptoms, lung function, and reliever use profile surrounding an event in the 2 treatment arms.;Primary end point(s): Individual patient profiles of daily variations over time in FeNO (morning), asthma symptom scores (morning and evening), PEF and FEV1 (morning and evening), and occasions of reliever medication use for the 24 weeks of treatment.;Timepoint(s) of evaluation of this end point: daily monitoring over 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Individual patient profiles of daily variations over time in FeNO (morning), asthma symptom scores (morning and evening), PEF and FEV1 (morning and evening), and occasions of reliever medication use between 14 days prior to and 28 days after an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb.;Timepoint(s) of evaluation of this end point: 14 days before and 28 after an event | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Astra Zeneca AB
Outcome results
None listed