A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 µg o.d.) in patients with moderate to severe COPD using tiotropium (18 µg o.d.) as an active control.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 148

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, 2006) and:
a)Smoking history of at least 10 pack years (current or previous smokers)
b)Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
c)Post-bronchodilator FEV1/FVC < 70%
(‘Post-’ refers to 15-30 min after inhalation of 400 µg of salbutamol at Visit 1)

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, 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
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 post-menopausal: 12 months of natural 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:surgical sterilization, hormonal contraception, double-barrier methods
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 oxygen therapy for chronic hypoxemia.
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
6.Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis
7.Patients with a history of asthma including all patients with:blood eosinophil count > 400/mm3, onset of asthma 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 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 unstable ischemic heart disease, arrhythmia , 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
11.Any patient with lung cancer or a history of lung cancer
12.Any patient with active cancer or a history of cancer with less than 5 years disease free survival time . Localized basal cell carcinoma of the skin is acceptable. Patients with a history of cancer and 5 years or more disease free survival time may only be included in the study by agreement with Novartis Headquarters personnel on a case-by-case basis
13.Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged: > 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 should not be re-screened.
14.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
15.Patients who do not maintain regular day/night, waking/sleeping cycles
16.Patients who have had treatment with other investigational dru

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials