A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 µg ‘as needed’ compared with Pulmicort (budesonide) Turbuhaler 200 µg twice daily plus terbutaline Turbuhaler 0.4 mg ‘as needed’
- Conditions
- English AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-004473-28-SK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4114
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 with a documented history of at least 6 months prior to Visit 1
4. Patients who are in need of GINA step 2 treatment:
- uncontrolled on an inhaled short acting bronchodilator(s) as needed (short acting beta2 agonist 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 (short acting beta2 agonist 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(s) only should have pre-bronchodilator FEV1 = 60 % of predicted normal (PN) and post- bronchodilator FEV1 = 80 % of PN according to the European Respiratory Society (ERS) guidelines (Quanjer at 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 test 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 411
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3292
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 411
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 or in the study D589SC00001 (SYGMA 1)
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method