A 52-week treatment, multicenter, randomized, double-blind, double dummy, 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 formoterol (12 µg bi.d.) as an active control - COPD 1 year, formoterol comparator
- Conditions
- Chronic obstructive pulmonary disease (COPD)
- Registration Number
- EUCTR2005-004168-21-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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 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 b2-agonist has been inhaled, and 48 h for long-acting b2-agonists.
c)Pre-bronchodilator FEV1/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
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 post-menopausal: 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 (> 6 months) oxygen therapy 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 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, 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 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
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