A 26-week treatment, multicenter, randomized, doubleblind, double dummy, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol selected from 75, 150, 300 600 g o.d. in patients with chronic obstructive pulmonary disease using blinded formoterol 12 g b.i.d and open label tiotropium 18 g o.d. as active controls - ND
- Conditions
- chronic obstructive pulmonary diseaseMedDRA version: 9.1Level: LLTClassification code 10009026Term: Chronic obstructive airways disease
- Registration Number
- EUCTR2006-001955-37-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1300
1. Male and female adults aged 8805; 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 8805;30 of the predicted normal value. c Post-bronchodilator FEV1/FVC 70 Post refers to within 30 min of inhalation of 400 g 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
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, post-ovulation 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 oxygen therapy 15 h a day for chronic hypoxemia. prn use up to 10 h total in any given 24 h period is acceptable . 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 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, 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
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