A 52-week treatment, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (200 & 400 µg o.d) in patients with chronic obstructive pulmonary disease using open label tiotropium (18 µg o.d) as an active control - COPD 1 year, tiotropium comparator

Conditions: Chronic obstructive pulmonary disease (COPD)

Registration Number: EUCTR2005-004169-41-DE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1304

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 consistent with the GOLD Guidelines (2005) and:
a)Smoking history of at least 20 pack years.
b)Pre-bronchodilator FEV1 at Visit 2 and Visit 3 < 65% of the predicted normal value. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 h during which no short-acting b2-agonist has been inhaled, and 48 h for long-acting b2-agonists.
c)Pre-bronchodilator FEV1 at least 0.75 L and FVC < 70%

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 pre-specified definition of post-menopausal OR are using pre-defined 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 long term oxygen therapy for chronic hypoxemia.
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 with contraindications for tiotropium treatment including symptomatic prostatic hypertrophy, bladder neck obstruction or narrow angle glaucoma.
10.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, 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.
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 prolonged QTc (Bazett’s) intervals (> 450 ms males; > 470 ms females)
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 (other than as prescribed in the study): 7 days
b)Short acting anti-cholinergics: 8 h
c)Fixed combinations of b2-agonists and inhaled corticosteroids: 48 h
(Patients taking fixed dose combination therapy must switch to inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy)
d)Long-acting b2-agonists: 48 h
e)Short acting b2-agonists (other than those prescribed in the study): 6 h
f)Theophylline and other xanthines: 1 month
g)Parenteral