chronic obstructive pulmonary disease (COPD) 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
CAS Number: 312753-06-3
Current Sponsor code: QAB149
Concen
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 10 pack years (current or previous smokers) 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 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 are using one or more of the following acceptable methods of contraception:surgical sterilization, hormonal contraception, double-barrier methods 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 for chronic hypoxemia. 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 6.Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis 7.Patients with a history of asthma including all patients with:blood eosinophil count > 400/mm3, 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 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 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 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 (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 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 other investigational dru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if indacaterol (150 µg o.d. and/or 300 µg o.d.) is superior to placebo in terms of 24 h post dose trough FEV1 after 14 days of treatment in each treatment period in patients with COPD.;Secondary Objective: -To determine if indacaterol are at least non-inferior to 18 µg tiotropium in terms of 24 h post-dose trough FEV1 after 14 days of treatment in each treatment period in patients with COPD. -To evaluate the effects of indacaterol and tiotropium in terms of peak effect and time to peak effect level as determined by FEV1 on Day 1 of treatment in each treatment period. -To evaluate the area under the FEV1 time curves (0-24 h) on Day 1 and Day 14 in each treatment period -To evaluate the effects of indacaterol and tiotropium in terms of 24 h post-dose trough FEV1 after 1 day of treatment in each treatment period. Treatment comparison will be made for FEV1 at each scheduled time point. -To evaluate the safety of indacaterol in terms of vital signs, glucose and potassium, ECG and adverse events. -To explore the pharmacokinetics of indacaterol after single (on Day 1) and multiple (on Day 14) dose administration. ;Primary end point(s): "Primary efficacy variable: Trough FEV1 after 14 days of treatment in each treatment period for superiority of indacaterol (150 o.d. and 300 µg o.d.) versus placebo." Therefore, the primary endpoint is the trough FEV1 post Day 14 dose. This is measured on Day 15 in each of the 3 treatment periods. This relates directly to the primary objective of the study. | — |
Countries
Germany, Netherlands, Spain
Outcome results
None listed