COPD: chronic obstructive pulmonary disease MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Indacaterol maleate
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol maleate
Current Sponsor code: QAB149
Concentration unit: µg
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the study the patient must satisfy all inclusion / exclusion criteria at Visit 1, and prior to randomization at Visit 3 unless specified otherwise. 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, Appendix 5) and including: a) Smoking history of at least 20 pack years b) Post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 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. 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 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 1. Patients who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue from the trial, but may (subject to agreement from the Novartis Medical Monitor) be permitted to re-enroll at a later date (at least 6 weeks after the resolution 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 and 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, 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. 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 acceptable. Patients with a history of cancer (excluding lung 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 12. Patients with a history (or family 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 (with the exc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate superiority of indacaterol (150 µg) versus placebo with respect to 24 h post-dose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of treatment in patients with COPD. The 24 h post dose trough FEV1 is defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post-dose.;Secondary Objective: •To compare indacaterol (150 µg o.d.) to placebo on spirometry assessments in terms of: - trough FEV1 measured on Day 2 - FEV1 measured at all time points, including approximate peak response (Day 1 and after 12 weeks treatment) and trough response. - the standardized AUC for FEV1 (5 min – 4 h), (5 min – 1 h) and (1 h – 4 h) on Day 1 and after 12 weeks of treatment. • To assess the 12 week safety (particularly with regard to ECG, laboratory tests, blood pressure and adverse events) of indacaterol (150 µg o.d.).;Primary end point(s): The primary end-point is the 24h trough FEV1 (indacaterol 150 mcg versus placebo) after 12 weeks treatment. | — |
Countries
Denmark, France, Germany, Lithuania, United Kingdom
Outcome results
None listed