None listed
Conditions
Interventions
Group 1 Type of group
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
Group name:Group 2 Type of group
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
16 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Have given the informed consent signed and dated on Visit 1 and before any specific study procedure. For underage patients, informed consent signed by both the patient and the patient´s parent / legal guardian is required. • Outpatients of any sex> 16 years in the Visit 1 • Asthma diagnosis according to GINA 2007 with a documented history of at least 6 months before Visit 2 • FEV1> 50% of the normal pre-bronchodilator predictive value • Reversible airway obstruction (according to the reversibility test performed in Visit 2) defined as an increase in FEV1> 12% relative to baseline for all patients, 15-30 minutes after inhalation in total 2 x 0.4 mg terbutaline (administered dose) Turbuhaler • Prescribed use of inhaled GCS (any brand) for at least 12 weeks before Visit 2 • The prescribed daily dose of GCS inhaled during the last 4 weeks prior to Visit 2 must have been constant and at least 400 pg / day of Futicasone or Qvar, at least 600 pg / day of budesonide, at least 1000 pg / day of any other beclomethasone dipropionate (BDP) or equivalent dose of any other inhaled GCS (GINA 2007) • A history of at least one asthma exacerbation, as defined in Section 3.1, the last 12 months prior to Visit 2 • Use of rescue medication due to asthma symptoms on at least 5 of the last 7 days of the Induction period, not including the day of Visit 3 • Be able to use the FEP meter and the Turbuhaler and correctly complete the diary • Have a record of the morning FEP values ​​of at least 8 of the last 10 days of the induction period (Including the value obtained on the morning of Visit 3) • No more than 10 rescue medication inhalations on any day of the Induction period • The patient must not have had an asthma exacerbation, as defined in Section 3.1, during the Induction period • The patient must be eligible for the study according to the exclusion criteria
Exclusion criteria
Exclusion criteria: • Be involved in the planning and / or conduct of the study (applies to both .4siraZeneca staff and to the study site) • Prior randomization of treatment in this study • Participation in another clinical study during the course of the study or within 4 weeks prior to Visit 2 • Known or suspected hypersensitivity to study therapy or excipient • respiratory infection affecting asthma, according to the investigator´s criteria, within 4 weeks prior to Visit 2 • Oral, rectal or parenteral taking of GCS within 4 weeks and / or parenteral GCS deposit within 12 weeks prior to Visit 2 • Use of p-blocking agents, including eye drops • Current or former smoker with a history of smoking> 10 packages per year • Any illness or disorder that, according to the investigator´s criteria, can either put the patient at risk by participating in the study or influencing the results of the study, or the patient´s ability to participate in the study. • Any clinically relevant abnormal finding on the physical examination, laboratory variables, vital signs or ECG at Visit 2. that may, in the opinion of the researcher, put the patient in danger due to their participation in the study • Pregnancy, lactation or pregnancy planned during the study. Women of childbearing age who are not using acceptable contraceptive measures, according to the investigator´s criteria • Hospitalization planned during the study • Low capacity, according to the investigator´s criteria, to follow the study instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment. Measure:The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study Timepoints:week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. Measure:Number of Asthma Exacerbations Timepoints:up to 52 weeks ; Outcome name:The mean value from a 52-week treatment period. Measure:Morning Peak Expiratory Flow (PEF) Timepoints:52-week treatment period ; Outcome name:The mean value from a 52-week treatment period. Measure:Evening PEF Timepoints:2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period ; Outcome name:The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. Measure:Forced Expiratory Volume in One Second (FEV1) Timepoints:4, 12, 24, 36 and 52 weeks after randomization ; Outcome name:The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). Measure:Use of As-needed Medication Timepoints:52-week treatment period ; Outcome name:The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). Measure:Asthma Symptom Score Timepoints:52-week treatment period ; Outcome name:The mean value from the treatment period was presented here. Measure:Nights With Awakening(s) Due to Asthma Symptoms Timepoints:52-week treatment period ; Outcome name:Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. Measure:The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations Timepoints:up to 52 weeks ; Outcome name:A sympt | — |
Countries
Argentina, Brazil, China, Costa Rica, Hungary, India, Japan, Korea South, Malasya, Peru, Philippines, Russian Federation, Thailand
Contacts
Public ContactUrsula Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed