Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-090-06
- 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. 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%.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Valley of FEV1 in Visit 9.<br>Timepoints:Week 12.<br>
- Secondary Outcome Measures
Name Time Method