moderate chonic obstructive pulmonary disease (COPD) MedDRA version: 12.0 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol maleate
CAS Number: 753498-25-8
Current Sponsor code: QAB149
Concen
Sponsors
Novartis Pharma GmbH
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 as classified by the GOLD Guidelines, 2008) and including: a. Smoking history of at least 10 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. Patients who received any Corticosteroid (esp. ICS resp. FDC) for 3 months prior to screening 2. Women who are pregnant or breast feeding and who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index 40 kg/m2 4. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening (Visit 1). In the event of an exacerbation occurring during the run-in period (Visits 1-2), the patient must discontinue from the study. The patient may be re-screened once the inclusion/exclusion criteria have been met 5. Patients requiring oxygen therapy for chronic hypoxemia 6. 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 2 must discontinue from the trial, but may be re-screened at a later date once the inclusion/exclusion criteria have been met 7. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), or clinically significant bronchiectasis 8. Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to): a. onset of respiratory symptoms (such as cough, wheezing, shortness of breath) suggestive of asthma prior to age 40 years b. history of a diagnosis 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 hemoglobin measured at Visit 1 10. Patients with contraindications for tiotropium treatment including medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow angle glaucoma and moderate to severe renal impairment (creatinine clearance = 50 mL/min) 11. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding chronic stable atrial fibrillation) or other clinically significant ECG findings, uncontrolled hypertension and other significant cardiac disease or conduction defect, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the opinion of investigator might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 12. Patients with lung cancer or a history of lung cancer 13. Patients with active malignancy or a history of malignancy of any organ system 14. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 1 is prolonged: >450 ms (males) or >470 ms (females) 15. Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof 16. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g. night shift workers) 17. Patients who have had treatment with any investigational drugs at the time of en
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of indacaterol (150µg o.d.) compared to placebo with respect to Peak Inspiratory Capacity after 21 days of treatment.;Secondary Objective: Key Secondary Objective •To demonstrate the non-inferiority of indacaterol (150µg o.d.) compared to open label tiotropium (18µg o.d.) with respect to Peak Inspiratory Capacity (IC) after 21 days of treatment. ;Primary end point(s): The primary objective of the study is to demonstrate that the efficacy of indacaterol is superior to placebo. Following this it should be shown as secondary objective, that indacaterol is not inferior to tiotropium (considering clinical relevance). Then, in a third step, superiority of indacaterol over tiotropium will be tested. | — |
Countries
Germany
Outcome results
None listed