A 52-week treatment, multicenter, randomized, doubleblind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol 300 600 g o.d. in patients with chronic obstructive pulmonary disease, using formoterol 12 g b.i.d. as an active control - ND

Conditions: COPD
MedDRA version: 8.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disorders

Registration Number: EUCTR2006-001954-28-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1716

Inclusion Criteria

Male and female adults aged 40 years; Co-operative outpatients with a diagnosis of COPD according to the GOLD Guidelines 2005 and a Smoking history of at least 20 pack years b Pre-bronchodilator FEV1 65 of the predicted normal value and at least 0.75 L. This criterion for FEV1 must be demonstrated after a washout period of at least 6 h during which no short-acting beta2-agonist has been inhaled, and 48 h for long-acting beta2-agonists. c Pre-bronchodilator FEV1/FVC 70
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or nursing lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test 5 mIU/mL 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal 12 months of natural spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels 40 mIU/mL OR are using one or more of the following acceptable methods of contraception a surgical sterilization e.g., bilateral tubal ligation, hysterectomy b hormonal contraception implantable, patch, oral c double-barrier methods any double combination of IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence e.g., calendar, ovulation, symptothermal, postovulation methods and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation. 3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period 4. Patients requiring long term 6 months oxygen therapy for chronic hypoxemia. prn use up to 10 h total in any given 24 h period is acceptable. Nocturnal oxygen use is permitted for patients who reside in a location where the elevation is 8805; 1500 meters 5000 feet above sea level 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue from the trial, but may be permitted to re-enroll at a later date at least 6 weeks after the start of the respiratory tract infection . 6. Patients with concomitant pulmonary disease, pulmonary tuberculosis unless confirmed by chest x-ray to be no longer active or clinically significant bronchiectasis 7. Patients with a history up to and including Visit 1 of asthma indicated by but not limited to a Blood eosinophil count 400/mm3 b Onset of respiratory symptoms prior to age 40 years 8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c 8.0 of total Hb measured at Visit 1 9. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as but not limited to unstable ischemic heart disease, arrhythmia excluding stable AF , uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 10. Any patient with lung cancer or a history of lung cancer 11. Any patient with active cance