Asthma
Conditions
Interventions
Trade Name: Symbicort Turbuhaler, 160 micrograms/4.5 micrograms/inhalation, inhalation powder
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentratio
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients should fulfil the following criteria: 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient’s parent/legal guardian is required 2. Outpatients of either gender aged =12 years at Visit 1 3. Diagnosis of asthma according to GINA criteria based on symptoms with a documented history of at least 6 months prior to Visit 1. Lung function and reversibility tests performed as part of Visit 2 and 3 can be used as a confirmation of asthma diagnosis according to GINA criteria if there is no measure of lung function available before Visit 1. 4. Patients who are in need of GINA (2012) step 2 treatment: - uncontrolled on inhaled short-acting bronchodilator(s) ‘as needed’ (SABA and/or short acting anticholinergic agent) as judged by the investigator for the last 30 days before Visit 2, or - controlled on mono-maintenance therapy - with low stable dose ICS (= 400 µg budesonide per day or corresponding dose of other ICS) (see Appendix E for conversion) or LTRA - in addition to 'as needed' use of inhaled short-acting bronchodilator(s) (SABA and/or short acting anticholinergic agent), as judged by the investigator for the last 30 days prior to Visit 2 5. Based on lung function tests (see Section 5.1.2) at Visit 2, patients pre-treated with ? an inhaled short acting bronchodilator only should have pre-bronchodilator FEV1 = 60 % of predicted normal (PN) and post-bronchodilator FEV1 = 80 % PN according to the European Respiratory Society (ERS) guidelines (Quanjer et al 2012) - low dose ICS or LTRA medication in addition to inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN according to the ERS guidelines 6. Reversible airway obstruction according to a reversibility test (see Section 5.1.2.2) performed at Visit 2 defined as an increase in FEV1 =12% and 200 ml relative to baseline, after inhalation of 1 mg Bricanyl Turbuhaler. The test can be repeated at Visit 3 in case the patients fail at Visit 2. If patients fail at both occasions, they can still be included if they have a documented historical reversibility within the last 12 months prior to Visit 3, with an increase in FEV1 =12% and 200 ml relative to baseline after administration of a rapid acting ß2-agonist For randomisation at Visit 3, patients should fulfil the following criteria: 7. Use of Bricanyl Turbuhaler ‘as needed’ due to asthma symptoms on at least 3 separate days during the last week of the run-in period 8. Ability to use Turbuhaler correctly and to complete the eDiary correctly. Morning and evening data must be Are the trial subjects under 18? yes 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 3375 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous randomisation in the present study 3. 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 4. Participation in another clinical trial with any marketed or investigational biologic drug within 4 months or 5 half-lives whichever is longer, prior to Visit 1 5. Any asthma worsening requiring change in asthma treatment other than inhaled short-acting bronchodilator(s) (SABA and/or short acting anticholinergic agent) within 30 days prior to Visit 1 6. Use of oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 7. Use of any ß-blocking agent including eye-drops 8. Known or suspected hypersensitivity to study drugs or excipient 9. Smoker (current or previous) with a smoking history of = 10 pack years 10. Medical history of life- threatening asthma including intubation and intensive care unit admission 11. Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study 12. Any clinically relevant abnormal findings in physical examination and/or vital signs at Visit 2, which, in the opinion of the investigator, may put the patient at risk if participating in the study 13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator 14. Planned hospitalisation during the study 15. Suspected poor capability, as judged by the investigator, of following instructions of the study. For randomisation at Visit 3, patients should not fulfil any of the following criteria: 16. Use of = 6 Bricanyl Turbuhaler ‘as needed’ inhalations per day, for a certain number of days depending on the actual length of run-in: for = 2 days out of 14 days; for =3 days out of 15-21 days; for = 4 days out of 22 or more days of run-in. 17. Any asthma worsening requiring change in asthma treatment other than inhaled short-acting bronchodilator(s) (SABA and/or short acting anticholinergic agent) from Visit 1 until Visit 2 and/or requiring any asthma treatment other than run-in study medication from Visit 2 until randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Symbicort Turbuhaler 160/4.5 µg ‘as needed’ is superior to terbutaline Turbuhaler 0.4 mg ‘as needed’.;Secondary Objective: 1.To evaluate the relative efficacy of Symbicort Turbuhaler 160/4.5 µg ‘as needed’ and Pulmicort Turbuhaler 200 µg twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’. 2.To evaluate the efficacy of Symbicort Turbuhaler 160/4.5 µg as compared to both: terbutaline Turbuhaler 0.4 mg ‘as needed’ And: Pulmicort Turbuhaler 200 µg twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’. ;Primary end point(s): Evaluation of asthma control as measured by well-controlled asthma weeks as the primary variable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first severe asthma exacerbation Time to first moderate or severe asthma exacerbation Average change from baseline in pre-dose FEV1 Average change from baseline in Morning PEF Average change from baseline in Evening PEF Average change from baseline in number of inhalations of ‘as needed’ medication Average change from baseline in symptom score Percentage of Nighttime awakenings due to asthma Percentage of Symptom-free days Percentage of ‘As needed’ free days Percentage of Asthma control days Time to asthma related discontinuation Poorly controlled asthma weeks Time to additional steroids for asthma Average change from baseline in Asthma Control Questionnaire (ACQ-5) Average change from baseline in Asthma Quality of Life Questionnaire; standard version (AQLQ(S)) | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Hungary, Korea, Republic of, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Ukraine, United Kingdom, Vietnam
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed