None listed
Conditions
Interventions
Target patient population
The target population includes male and female patients who are ≥
12 years old and who
have a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1.
Patients who are either uncontrolled on short acting β
2 agonist ‘as needed’ or who are
controlled on mono-maintenance therapy with low stable dose inhaled corticosteroid or a
leukotriene receptor antagonist for the last 30 days before Visit 2 will
2 agonist on at least 3 separate days during the last week of the run-in period.
Duration of treatment
This study starts with an enrolment visit (Visit 1) where informed consent is obtained and
2 agonist (Bricanyl)
‘as needed’ only. Eligible patients will be randomised at Visit 3 and enter a 52-week
double-blind treatment period. Two weeks after the completion of study treatment a
f
g (budesonide 160 μ
g and formoterol fumarate dihydrate
4.5 μ
g per inhalation, powder for inhalation in a dry powder inhaler) used ‘as needed’ (to
relieve asthma symptoms) in addition to Placebo for budesonide (powder for inhalation in
a dry powder inhale
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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 for GINA step 2 treatment: − uncontrolled on SABA ‘as needed’ 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 LTRAs 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 − a SABA 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 LTRAs medication 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 on low dose ICS or LTRAs 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 β2-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 recorded for at least 8 days (any 8) of the last 10 days of the run-in period
Exclusion criteria
Exclusion criteria: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous enrolment 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 SABA 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 β-blocking agent including eye-drops 8. Known or suspected hypersensitivity to study drugs or excipient 9. Current or previous smoker 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 runin. 17. Any asthma worsening requiring change in treatment other than SABA from Visit 1 until randomisati
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Mauritania, Mexico, Poland, Russian Federation, South Africa, Ukraine, United Kindgdom
Contacts
Public ContactUrsula Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed