moderate to severe COPD (chronic obstructive pulmonary disease) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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 amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 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 period between Visit 2 and Visit 3. 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 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 . 7. Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis 8. Patients with a history of asthma 9. 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 2. 10. Patients who 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 (excl. 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. 13. Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 or Visit 3 is prolonged: > 450 ms (males) or > 470 ms (females) as assessed by the central ECG interpretation or investigator’s interpretation of the pre-dose ECGs. 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 investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 2, whichever is longer. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evening dosing of indacaterol vs. placebo: To assess the efficacy of indacaterol 300 µg o.d. when dosed in the evening compared to placebo in patients with moderate to severe COPD, as assessed by trough FEV1 at 23h 10min and 23h 45min post dose taken on Day 14. ;Secondary Objective: Safety: To assess the safety of indacaterol 300 µg dosed in the evening with regard to ECGs, laboratory tests, blood pressure, heart rate, and adverse events. Morning and evening dosing of indacaterol vs. placebo after 14 days treatment: To compare descriptively trough FEV1 of indacaterol 300 µg o.d. when dosed in the morning vs. placebo with trough FEV1 when dosed in the evening vs. placebo in patients with moderate to severe COPD. ;Primary end point(s): | — |
Countries
France, Germany, Spain
Outcome results
None listed