Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Indacaterol maleate
Current Sponsor code: QAB149
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2. Patients with moderate to severe stable COPD according to the GOLD Guidelines (2006) 3. Patients who have smoking history of at least 10 pack years. 4. Patients with a post-bronchodilator FEV1 =30% and =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 urine pregnancy test. 2. Women of child-bearing potential (WOCBP), 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 (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 (e.g., bilateral tubal ligation, hysterectomy) • hormonal contraception (implantable, patch, oral) • double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) (if accepted by local regulatory authority and ethical committee) Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. 3. Patients requiring long term oxygen therapy (> 15 hr a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the screening period (up to Visit 4). 4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection). 5. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis. 6. Patients with any history of asthma 7. Patients with blood eosinophil count > 400/mm3 8. 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, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (excluding stable AF), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 9. Patients with a history of episodes of cardiac failure, life threatening arrhythmias as seen during screening Holter monitoring and evidence of acute ischemic changes during the screening ECGs 10. Patients with uncontrolled diabetes Type I or 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. 11. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 12. Patients who are contraindicated for or who have shown an untoward re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 14 days treatment with QVA149 600µg/100µg, QVA149 300µg/100µg, QVA149 150µg/100µg on change in mean 24-h heart rate (ventricular rate) compared to placebo delivered by the Single Dose Dry Powder Inhaler (SDDPI) Concept 1 once a day in patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD). ;Secondary Objective: To evaluate the effect of 14 days treatment with QVA149 on change in mean 24-h heart rate compared to QAB149. To evaluate the effect of QVA149 on: Change in QTc at all time points assessed via ECGs on day 1, day 7 and day 14 24 hour Holter assessments on day 1 and day 14 in terms of Change in heart rate at 30min, 4h and 23h 45min hours post dose Number of Ventricular ectopic events including: Singular premature ventricular contraction (PVC) Couplets, defined as two PVCs preceded and followed by regular beats Non-sustained Ventricular tachycardia Ventricular tachycardia (VT) Supraventricular ectopic events Number of supraventricular tachycardia episodes (SVTs) including number of episodes of atrial fibrillation (AF) and atrial flutter To evaluate the effect of QVA149 on FEV1 and FVC measured at all time-points To evaluate adverse events, post-inhalation events (cough), vital signs, laboratory parameters in particular blood glucose and serum potassium;Primary end point(s): To assess the effect of 14 days treatment with QVA149 600µg/100µg, QVA149 300µg/100µg, QVA149 150µg/100µg on change in mean 24-h heart rate (ventricular rate) compared to placebo delivered by the Single Dose Dry Powder Inhaler (SDDPI) Concept 1 once a day in patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD). | — |
Countries
Belgium, France, Germany, Italy, Spain
Outcome results
None listed