A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 μg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 μg b.i.d.) as an active control - ND
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-111-07
- 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
• Adult men and women> 40 years of age, who have signed an Informed Consent Form before initiating any procedure related to the study.
• Cooperative outpatients with diagnosis of COPD (classified as moderate to severe according to the GOLD Guidelines, 2006) and: a) post-bronchodilator FEV1 <80% and> 30% of the predicted normal value b) FEV1 / FVC post-bronchodilator <70% c) FEV1 / FVC post-bronchodilator <70%. (Post refers to the 30 minutes following the inhalation of 400 ug of salbutamol equivalent to 4 x 90 of albuterol administered in the mouthpiece in Visit 1)
• Pregnant or lactating women, defining pregnancy as the status of a woman after conception and until the termination of pregnancy, confirmed by a positive human chorionic gonadotropin test (> 5mIU / ml).
• Women of childbearing age, defined as all women with physiological capacity to become pregnant, including women whose career, lifestyle or sexual orientation prevents sexual relations with a male partner and women whose partner has been sterilized by vasectomy or through another method, UNLESS they meet the following definition of post-menopause: 12 months of natural amenorrhea (spontaneous) or 6 months of spontaneous amenorrhea with serum FSH levels> 40niU / mo or using one or more of the following accepted contraceptive methods: a) Surgical sterilization (eg, bilateral tubal ligation, hysterectomy) b) hormonal contraceptives (implantable, patch, oral) c) double barrier methods (any combination of double IUD, male condom or -femenino-con-gel-espermicidardiafragmaresponja, cap cervical).
• Patients who have been hospitalized for an exacerbation of COPD within the 6 weeks prior to Visit 1 or during the run-in period.
• Patients requiring oxygen therapy for chronic hypoxemia (not including acute exacerbations of COPD). Typically this refers to patients who need oxygen therapy> 15 h daily by home oxygen or oxygen concentrator.
• Patients who have had an airway infection within 6 weeks prior to Visit 1. Patients who have an airway infection between Visit 1 and Visit 3, should be removed from the study, but are may allow re-incorporation later (minimum 6 weeks after the onset of respiratory infection).
• Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless it is confirmed that it will not be active through a chest x-ray) or clinically significant bronchiectasis.
• Patients with a history (up to Visit 1, inclusive) of asthma
• Patients with type I diabetes or uncontrolled type n diabetes including patients with a history of blood glucose levels outside the normal range or HbA1c> 8.0% of the total Hb measured in Visit 1.
• Patients who, in the opinion of the investigator or personnel in charge of Novartis, have a clinically relevant laboratory disorder or a clinically significant disease such as, among others, unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, hypoxia, uncontrolled hyperthyroidism, hypokalemia, hyperadrenergic state or any condition that in the opinion of the investigator could compromise the patient´s safety or compliance, may interfere with the evaluation or may prevent the completion of the study.
• Any patient with lung cancer or a history of this type of cancer
• Any patient with active cancer or a history of cancer with disease-free survival less than 5 years (whether or not there is evidence of metastasis or local recurrence). Localized basal cell carcinoma of the skin (without metastasis) is accepted. Patients with a history of cancer (excluding lung cancer) and a disease-free survival of 5 years or more can only be included in the study by agreement with the staff of the Novartis headquarters in accordance with each case.
• Patients with a history (personal or family) of long QT syndrome or with a QTc interval (Bazett) prolonged> 450 ms (men) or> 470 ms (women) measured in Visit 1 or Visit 3, depending on the central interpretation of the ECG or the interpretation of the predose ECGs made by the resear
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Valley FEV1 is defined as the average of the values of 23 h 10 min and 23 h 45 min taken in the clinic only in Visits 4, 9 and 13<br>Measure:FEV1 valley in Visit 9<br>Timepoints:Visit 9<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Valley FEV1 is defined as the average of the values of 23 h 10 min and 23 h 45 min taken in the clinic only in Visits 4, 9 and 13<br>Measure:FEV1 valley on Day 2 and after 26 weeks of treatment<br>Timepoints:Day 2 and after 26 weeks of treatment<br>;<br>Outcome name:The measurements of FEV1 taken in the first 6 hours of use of the rescue medication will be given as losses. No FEV1 measurement will be imputed.<br>Measure:FEV1 and FVC for 12 hours post morning dose<br>Timepoints:12 hours post morning dose<br>;<br>Outcome name:The peak FEV1 defined as the maximum FEV1 during the first 4 hours after the morning dose will be calculated in Visits 3, 8 and 12 in all patients in the ITT population of the 4-hour serial spirometry subgroup.<br>Measure:FEV1 peak for 4 hours post morning dose<br>Timepoints:4 hours post morning dose<br>