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

Not Applicable

Completed

• Conditions: -J449 Chronic obstructive pulmonary disease, unspecified; Chronic obstructive pulmonary disease, unspecified; J449

• Registration Number: PER-111-07
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-10
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• 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)

Exclusion Criteria

• 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