Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
- Conditions
- -J45J45
- Registration Number
- PER-049-07
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Criteria 1 and 2: Peripheral blood levels of Potassium and Glucose.<br>Criterion 3: Clinical evaluation of heart rate, diastolic and systolic blood pressure.<br>Criterion 4: Average of 2 or 3 standard 12-lead electrocardiograms. The QTc will be analyzed with special emphasis.<br>Measure:Safety: 1) Serum potassium. 2) Serum glucose. 3) Vital signs. 4) Electrocardiogram.<br>Timepoints:Criteria 1,2 and 3: Weeks 1, 3, 9, 12 and 26.<br>Criterion 4: Weeks 1, 3, 9, 12, 17, 21 and 26.<br>
- Secondary Outcome Measures
Name Time Method