moderate to severe 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
Current Sponsor code: QAB149
Concentration unit: µg microgram(s)
Concentration type: equal
C
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: d) Smoking history of at least 20 pack years e) 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 2. Women of child-bearing potential, 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: • surgical sterilization • hormonal contraception • double-barrier methods 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 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 2 or during the run-in period 4. Patients requiring long-term oxygen therapy (>15 h a day) for chronic hypoxemia. 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection between Visit 2 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 (up to and including Visit 2) of asthma indicated by at least one of the following: a) blood eosinophil count >400/mm3 b) 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 glycosylated hemoglobin (HbA1c) >8.0% of total hemoglobin measured at Visit 2 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. 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-bycase basis 12. Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 2 or Visit 3 is prolonged: >450 ms (males) or >470 ms (females) as assessed by the central ECG interpretation (Visit 2) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened 13. 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 14. Patients who do not maintain regular day/night, waking/sleeping cycles 15. Patients who have had treatment wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if indacaterol (150 and/or 300 µg) is superior to placebo in terms of FEV1 at 5 mins post-dose.;Primary end point(s): The primary endpoint is to determine if indacaterol (150 and/or 300 µg) is superior to placebo in terms of FEV1 at 5 mins post-dose in patients with COPD.;Secondary Objective: - To compare the effects of indacaterol (150 and 300 µg) versus salmeterol/fluticasone (50/500 µg) in terms of FEV1 at 5 mins post-dose. - To compare the effects of indacaterol (150 and 300 µg) versus salbutamol (200 µg) in terms of FEV1 at 5 mins post-dose. - To compare the effects of salmeterol/fluticasone (50/500 µg) and salbutamol (200 µg) versus placebo in terms FEV1 at 5 mins post-dose. - To evaluate the effects of indacaterol (150 and/or 300 µg), salmeterol/fluticasone (50/500 µg), salbutamol (200 µg) and placebo in terms of: • Proportion of patients with at least 10, 12 and 15% increase in FEV1 from period baseline at 5, 15 and 30 mins, and 1 and 2 h post-dose • Proportion of patients with at least 12% and 200 mL increase in FEV1 from period baseline at 5, 15 and 30 mins, and 1 and 2 h post-dose • FEV1 at 15 and 30 mins, and 1 and 2 h post-dose - To compare the effects of indacaterol 150 µg versus indacaterol 300 µg in terms of FEV1 at 5 mins post-dose. | — |
Countries
Germany, Hungary
Outcome results
None listed