None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Budesonide / Formoterol, in a Pressurized Inhaler at Doses Measurements (pMDI), at a dose of 160 / 4.5 ug, 2 applications, BID + Formoterol Placebo in dry powder for inhalation, 2 inhalations, BID. This scheme will be administered for 12 months.
Group name:GROUP 3 Type of group
Este grupo sera tratado con Budesonida/Formoterol Placebo, en un Inhalador Presurizado a Dosis Medidas (pMDI), 2 aplicaciones, BID + Formoterol en polvo seco para inhalacion, a una dosis de 4.5 ug, 2 inhalaciones, BID. Este esquema sera administrado por 12 meses.
Sponsors
ASTRAZENECA - PERU,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Visited Informed Consent 1 obtained prior to the completion of any procedure related to the study. 2. Outpatient; men or women ≥ 40 years of age. 3. A current diagnosis of COPD with COPD symptoms for more than 2 years. 4. Current smoker or former smoker with a history of smoking equivalent to 10 or more years / pack. 5. FEV1 ≤ 50% of the normal value predicted prior to the bronchodilator. 6. FEV1 / FVC of <70% prior to bronchodilator 7. Documented use of a short-acting inhaled bronchodilator as rescue medication before the study. 8. A score of ≥ 2 on the dyspnea scale of the MMRC at Visit 2. 9. History of at least 1 exacerbation of COPD that required a course of steroids and / or antibiotics within 1-12 months prior to Visit 1. 10. The ability to comply with all study procedures and to take study medication in a satisfactory manner. 11. The ability to perform a 6-minute walk test. 12. Ability to read and write and use electronic devices.
Exclusion criteria
Exclusion criteria: 1. History of asthma after 18 years of age. 2. History of allergic rhinitis from 18 years of age. 3. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension, or any other relevant cardiovascular disorder. 4. Known deficiency of alpha-1 antitrypsin in homozygotes. 5. Any significant disease or disorder that could put the subject at risk due to participation in the study, or the influence of the study results, or the subject´s ability to participate in the study. 6. History of malignancy in the past 5 years. 7. Subjects who have needed additions or modifications to the usual maintenance or changes in the formulation of rescue therapy for COPD due to a worsening of symptoms within 30 days prior to Visit 1. 8. Subjects taking non-cardioselective ophthalmic or oral B-blocking agents. 9. Subjects who take oral steroids. 10. Subjects who are currently in the intensive phase of rehabilitation or scheduled to begin a new participation in a rehabilitation program for COPD during the study or who have initiated a new rehabilitation program for COPD within 60 days from Visit 1. 11. Known or suspected hypersensitivity to study therapy or excipients of investigational products. 12. Hospitalization planned during the study. 13 Pregnancy, lactation or pregnancy planned during the study; fertile women who do not use acceptable contraceptive measures. 14. Subjects that have participated in a clinical study that evaluates the investigational drug in the last 30 days prior to Visit 1, or that have been previously assigned to a randomized code in this study. 15. Subjects with a history of a condition of non-compliance or with a history of poor compliance with therapy. 16. Being involved in the planning or conduction of the study. 16. Being involved in the planning or conduct of the study. 17. At Visit 3, subjects who have needed additions or modifications to usual maintenance or changes in the formulation of rescue therapy for COPD due to worsening of symptoms from Visit 2. 18. Any clinically relevant abnormal findings in the physical examination, clinical chemistry, hematology, vital signs or ECG at the baseline visit, which may put the subject in danger due to their participation in the study. 19. Blood donation planned during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Counting the number of exacerbations presented by the patient from randomization to 12 months of treatment. An exacerbation of COPD is defined as a symptomatic worsening that required a course of oral corticosteroids and / or hospitalization. Measure:Number of COPD exacerbations during the period of randomized treatment. Timepoints:At 12 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Determination of the time from randomization to the symptomatic worsening that required a course of oral corticosteroids and / or hospitalization. Criterion 2: Standard spirometry, 3 forced expiratory maneuvers will be performed, calculating FEV1 and FVC, based on the total expiratory flow-volume-time curve. Criteria 3, 4, 5 and 6: Journal of the patient. Criterion 7: The BODE index is a composite of the body mass index (BMI), obstruction (FEV1), dystonia (MMRC scale) and exercise capacity (6-minute walk test). Measure:Secondary efficacy: 1) Time until the first COPD exacerbation. 2) FEV1 and FVC before dose. 3) Morning and afternoon PEF. 4) Disnea. 5) Symptoms of COPD. 6) Use of rescue medication B2-agonist. 7) BODE index. Timepoints:At 12 months of treatment. ; Outcome name:SGRQ, is a questionnaire that assesses the impact of respiratory disease on health status, contains 3 fields: Symptoms, Activity and Impacts. Measure:Change from baseline in the total score to the end of the treatment in the St. George Hospital Respiratory Distress Questionnaire (SGRQ). Timepoints:At 12 months ; Outcome name:Measurement of: Use of the study drug, Use of rescue medication, Hospitalization, Visits to the Emergency Room Urgent care visits, Unscheduled visits to the healthcare provider, Use of oral steroids, Loss activity and Lost work days. Measure:Health economics. Timepoints:When the events are presented. ; Outcome name:Criterion 1: Clinical evaluation of all adverse events that: a) Result in death. b) It puts life at risk immediately. c) Requires hospitalization of the patient or prolongation of an existing hospitalization. d) It results in a persistent or significant disability. e) It is a congenital anomaly or a birth defect. f) It is an important medical event that could endanger the subject or could require medical intervention to avoid one of the results listed above. Criterion 2: The pu | — |
Countries
Argentina, Brazil, Chile, Colombia, Peru, South Africa, United States, Venezuela
Contacts
Public ContactEduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed