Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Seebri Breezhaler
Product Name: Glycopyrronium bromide
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596
Sponsors
Novartis Pharma GmbH
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 COPD defined by a post-bronchodilator FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: o History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. o History of malignancy of any organ system, 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. o Patients, who have already been randomized into this trial earlier must not be included a second time. o Study personnel or first degree relatives of investigator(s) must not be included in the study. o Patients incapable of giving full informed consent. Women o who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)) o who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index 8%). 2. Patients with a history of long QT syndrome or whose QTc calculated at run-in (Bazett formula) is prolonged (>450 ms). These patients should not be re-enrolled. 3. Patients who have a clinically significant ECG abnormality at run-in. 4. Patients who have a clinically significant laboratory abnormality at run-in. 5. Patients with a body mass index (BMI) of more than 40 kg/m2. 6. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haemotological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment. 7. Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in (Visit 2) with a resting ventricular rate < 100/min. 8. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: a. Muscarinic antagonist agents b. long and short acting beta-2 agonists c. sympathomimetic amines d. lactose or any of the other excipients of the trial medication 9. Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered). 10. Patients who have not achieved acceptable spirometry results at run-in in accordance with ATS/ERS criteria for acceptability and repeatability. 11. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening. 12. Patients who develop a COPD exacerba
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that glycopyrronium bromide 44 µg q.d has superior efficacy compared to tiotropium 18 µg q. d. on early bronchodilation, determined by FEV1 AUC0 2h, in moderate to severe COPD patients.;Secondary Objective: To evaluate the effect of glycopyrronium bromide (44 µg q.d.) vs. tiotropium (18 µg q.d.) on lung function as measured by: • Forced Spirometry: FEV1 15 min post-dose • Bodyplethysmography o specific airway resistance (sRaw), o functional residual capacity (FRCpleth), o inspiratory capacity (IC), o residual volume (RV), o total lung capacity (TLC) at 30 min, 60 min, 90 min, 150 min, 210 min ;Primary end point(s): Early bronchodilation determined by FEV1 AUC0 2h;Timepoint(s) of evaluation of this end point: 2 h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Lung function as measured by: • Forced Spirometry: FEV1 15 min post-dose • Bodyplethysmography o specific airway resistance (sRaw), o functional residual capacity (FRCpleth), o inspiratory capacity (IC), o residual volume (RV), o total lung capacity (TLC) at 30 min, 60 min, 90 min, 150 min, 210 min ;Timepoint(s) of evaluation of this end point: Forced Spirometry: FEV1 15 min post-dose Bodyplethysmography o specific airway resistance (sRaw), o functional residual capacity (FRCpleth), o inspiratory capacity (IC), o residual volume (RV), o total lung capacity (TLC) at 30 min, 60 min, 90 min, 150 min, 210 min | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed