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

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 8.1Level: LLTClassification code 10010952Term: COPD

Registration Number: EUCTR2006-001954-28-LT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1716

Inclusion Criteria

1. Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines 2005) and:
a) Smoking history of at least 20 pack years
b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value
c) Post-bronchodilator FEV1/FVC < 70%
(Post refers to within 30 min after inhalation of 400 µg of salbutamol)
Are the trial subjects under 18? no
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 women 2. Women of child-bearing potential UNLESS they meet a pre-defined definition of post-menopausal, OR are using one or more pre-specified acceptable methods of contraception: 3. Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 2 or during the run-in period. 4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD exacerbation). This is typically patients requiring oxygen therapy >15 h per day delivered by home oxygen cylinder or concentrator. 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. 6. Patients with concomitant pulmonary disease including a history of lung cancer, pulmonary tuberculosis or clinically significant bronchiectasis. 7. Patients with a history (up to Visit 2) of asthma indicated by (but not limited to): a) Blood eosinophil count > 400/mm3 b) Onset of 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 > 6.5% of total Hb. 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, 11. Any patient with lung cancer or other active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable. 12. Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged to > 450 ms (males) or > 470 ms (females) as assessed by the central ECG interpretation (Visit 1) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened. 13. Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. 14. Patients who do not maintain regular day/night, waking/sleeping cycles 15. Patients who have had treatment with other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 16. Patients who have had live attenuated vaccinations within 30 days prior to Visit 2 and during the run-in period. (Influenza vaccination is acceptable provided it is not administered within 48 h prior to Visits 1 or 2). 17. Treatments for COPD and allied conditions: the following medications must not be used prior to Visit 2 for at least the minimum washout period specified below or at any time during the study: a) The long acting anti-cholinergic agent tiotropium: 7 days b) Short acting anti-cholinergics: 8 h c) Fixed combinations of beta-2-agonists and inhaled corticosteroids: 48 h (Patients taking fixed dose combination therapy must switch to inhaled