None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with: Indacaterol, in single dose dry powder inhaler (SDDPI), at a dose of 300 ug, QD, in the morning + Indacaterol Placebo, in single dose dry powder inhaler (SDDPI), QD, in the morning + Salbutamol Placebo, in inhaler, IDB
This group will be treated with: Indacaterol Placebo, single dose Dry Powder Inhaler (SDDPI), IDB, in the morning and at night + Salbutamol, in an inhaler, at a dose of 50 ug, IDB
this scheme will be administered for 26 weeks.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged ≥ 12 years, who have signed an informed consent form before the start of any procedure related to the study. In the case of patients below the legal age of consent, the Informed Consent Form must also be signed by a parent / guardian of the patient. 2. Patients with persistent moderate to severe asthma, diagnosed according to the GINA guidelines.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or breastfeeding. 2. Women with reproductive potential, UNLESS they meet the definition of a postmenopausal woman OR who are using one or more of the acceptable methods of contraception. 3. Patients who have consumed tobacco products within the 12-month period prior to Visit 1, or who have a history of cigarette consumption of more than 10 packs per year. 4. Patients suffering from COPD diagnosed by the GOLD guidelines. 5. Patients who have received treatment in the emergency room for an attack of acute asthma in the 6 months prior to Visit 1, or who have been hospitalized for an acute asthma attack in the 6 months prior to Visit 1. 6. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. 7. Patients with Type I diabetes or uncontrolled Type II diabetes. 8. Patients who have a clinically significant condition or a clinically relevant laboratory condition. 9. Any patient with active cancer or cancer history with less than 5 years of disease-free survival time. 10. Patients with a history of prolonged QT syndrome or whose QTc interval is prolonged to> 450 ms (men) or> 470 ms (women). 11. Patients with a history of hypersensitivity to any of the study drugs or drugs with similar chemical structures. 12. Patients who do not maintain regular cycles day / night, awake / sleeping. 13. Patients who have received live attenuated vaccinations within 30 days prior to Visit 1 or during the admission period. 14. Patients with a known history of non-compliance with medication or who are unable or unwilling to complete the Journal of the Patient on a daily basis. 15. The following medications should not be used prior to Visit 1 for at least the specified minimum washout period: a) Long-acting anticholinergic agent tiotropium: 7 days. b) Short-acting anticholinergics: 8 h. c) Fixed combinations of B2 agonists and inhaled corticosteroids: 48 h. d) Long-acting B2 agonist: 48 h. e) Short-acting B2 agonist: 6 h. f) Theophylline and other xanthines: 7 days. g) Parenteral and oral corticosteroids: 3 months. 16. The following medications should not be used unless they have been stabilized for at least one month prior to Visit 1: Cromoglycate, nedocromil, ketotifen, omalizumab, inhaled corticosteroids, and leukotriene antagonists. 17. Other medications excluded: a) Diuretics that do not save potassium. b) All beta-blocking agents. c) Class lA, Class III cardiac antiarrhythmics and any drug with the potential to significantly prolong the QT interval. d) Tricyclic antidepressants and monoamine oxidase inhibitors. e) Use of other research drugs at the time of recruitment, or within 30 days or 5 half-lives before Visit 1. 18. Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 2: Peripheral blood levels of Potassium and Glucose. Criterion 3: Clinical evaluation of heart rate, diastolic and systolic blood pressure. Criterion 4: Average of 2 or 3 standard 12-lead electrocardiograms. The QTc will be analyzed with special emphasis. Measure:Safety: 1) Serum potassium. 2) Serum glucose. 3) Vital signs. 4) Electrocardiogram. Timepoints:Criteria 1,2 and 3: Weeks 1, 3, 9, 12 and 26. Criterion 4: Weeks 1, 3, 9, 12, 17, 21 and 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Standard spirometry. Criterion 2: Mathematical calculation, based on the spirometry data. Criterion 3, 5, 7, 9, 10 and 11: patient s diary. Criterion 4, 6: The result of the Asthma Quality of Life Questionnaire with standardized activities - AQLQ (S), will be divided by the number of items (32). Criterion 6: The Maximum Expiratory Flow (FEP) will be measured with a spirometer for personal use. Criterion 8: The total symptom score (range 0 to 9) will be calculated as the total of the nocturnal symptom score (range 0 to 4), morning symptom score (range 0 to 1) and the diurnal symptom score (range) 0 to 4). Measure:1) Valley of the Flow of the Expiratory Volume in the first second (FVE1) and Full Life Capacity (CVP). 2) FEV1: AUC (30mln-2h). 3) Percentage of days without diurnal symptoms. 4) Total AQLQ (S) score. 5) Percentage of nights without night awakenings. 6) Morning and evening FEP. 7) Clinical symptoms. 8) Total score of symptoms, day and night punctuation. 9) Rescue use during the day and night. 10) Percentage of days without the use of rescue. 11) Exacerbation rates. Timepoints:Criteria 1, 2, 8: Weeks 1 - 26. Criterion 3, 5, 7, 9, 10 and 11: Week 26 Criterion 4: Weeks 1, 12 and 26. Criterion 6: Last 7 days before each visit. | — |
Countries
Argentina, Canada, Czech Republic, France, Germany, Hungary, Italy, Peru, Slovakia, Spain, Turkey, United States
Outcome results
None listed