None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Indacaterol 300 ug, in Single Dose Dry Powder Inhaler (SDDPI), QD + Formoterol Placebo 12 ug, in inhaler Aerolizer®, BID. This scheme will be administered for 52 weeks.
Group name:GROUP 4 Type of group
This group will be treated with Indacaterol Placebo, in Single Dose Dry Powder Inhaler (SDDPI), QD + Formoterol Placebo, in Aerolizer® inhaler, BID. This scheme will be administered for 52 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men and women of 40 years of age, who have signed an Informed Consent Form before initiating any procedure related to the study. 2. Cooperative ambulatory patients diagnosed with COPD and: a) History of smoking at least 20 packs per year. b) Pre-bronchodilator FEV1 <65% of predicted normal value and minimum 0.75 L. c) FEV1 / FVG pre-bronchodilator <70%.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Women of childbearing age, unless they meet the definition of post-menopause OR who are using one or more of the contraceptive methods accepted. 3. Patients who have been hospitalized for an exacerbation of COPD within 6 weeks prior to Visit 1 or during the period of onset. 4. Patients requiring long-term oxygen therapy for chronic hypoxemia. 5. Patients who have had an airway infection within 6 weeks prior to Visit 1. 6. Patients with concomitant lung disease. 7. Patients with a history of asthma. 8. Patients with type I diabetes or uncontrolled type II diabetes. 9. Patients who have a clinically relevant laboratory disorder or a clinically significant disease. 10. Any patient with lung cancer or a history of this type of cancer. 11. Any patient with active cancer or a history of cancer with a disease-free survival of less than 5 years. 12. Patients with a history of long QT syndrome or whose QTc interval (Bazett) is prolonged. 13. Patients with a history of hypersensitivity to any of the study drugs or to medicines with similar chemical structures. 14. Patients who do not maintain regular day / night, wake / sleep cycles. 15. Patients who have received treatment with another investigational medication at the time of incorporation or within 30 days or 5 half-lives prior to Visit 1, whichever is longer. 16. Patients who have received live attenuated vaccines within 30 days prior to Visit 1 or during the start period. 17. Treatment for COPD with certain medications, they must, at least have a minimum washing period. 18. The following medications should not be used unless they have a stable dose: a) Cromoglycate, nedocromil, ketotifen, omalizumab, inhaled or nasal corticosteroids and leukotriene antagonists - at least one month before Visit 1. b) Antihistamines - minimum 5 days before Visit 1. 19. Other drugs excluded: a) Not potassium-sparing diuretics. b) Non-selective beta-blocking agents. c) Class A, class IIl, cardiac antiarrhythmics, terfenadine, astemizole, mizolastin and any medication that can potentially prolong the QT interval. d) Tricyclic antidepressants and monoamine oxidase inhibitors. 20. Patients who are not able to use a dry powder inhaler device or perform spirometry measurements. 21. Patients who are not able or do not intend to complete a Patient Journal every day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Standard spirometry, 3 acceptable maneuvers will be performed, according to the ATS standards. Measuring the FEV1 valley, defined as the average of the values of 23 h 10 min and 23 h 45 min. Measure:Valley of FEV1 in Visit 9. Timepoints:Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Journal of the Patient: where a poor control day is defined as any day on which a score of 2 or more is recorded in at least two symptoms. Measure:Percentage of days of poor control of COPD. Timepoints:Weeks 52. ; Outcome name:1) Time for the first exacerbation of COPD: Clinical evaluation and information from the Patient s Journal, where an exacerbation is defined as: a) Recent onset or worsening of more than one respiratory symptom that are present for more than 3 consecutive days. MORE b) Change or documented increase in the treatment of COPD due to worsening of symptoms. c) Documented hospitalizations or visits to the emergency department due to COPD. 2) SGRQ: St George s Respiratory Questionnaire: Questionnaire of 76 items divided into two parts that cover 3 aspects of health, evaluating respiratory symptoms and disease activity. Measure:1) Time for the first COPD exacerbation. 2) Total SGRQ score. Timepoints:1) First exacerbation of COPD: When the event occurs. 2) SGRQ: After 12 weeks of treatment. ; Outcome name:Standard spirometry, 3 acceptable maneuvers will be performed, according to the ATS standards. Measuring the FEV1 peak, FVC, the FEV1 valley, defined as the average of the values of 23 h 10 min and 23 h 45 min. Measure:Spirometry: 1) Valley of FEV1 on Day 2 after 12 and 52 weeks of treatment. 2) FEV1 and FVC during 12 hours post morning dose. 3) FEV1 peak during 4 hours post morning dose. 4) FEV1: AUC (5 min -4h). 5) FVC: AUC (5m¡n-11h 45 min). 6) Response of FEV1 and FVC valley for 52 weeks. 7) Early response of FEV1 and FVC during 52 weeks. Timepoints:Weeks 1, 3, 5, 9, 12, 13, 17, 21, 24, 29, 37, 45 and 52. ; Outcome name:Journal of the Patient, where an exacerbation is defined as: a) Recent onset or worsening of more than one respiratory symptom that are present for more than 3 consecutive days. MORE b) Change or documented increase in the treatment of COPD due to worsening of sympto | — |
Countries
Belgium, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Hungary, Israel, Italy, Korea South, Latovia, Lithuania, Netherlands, Peru, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kindgdom
Outcome results
None listed