Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: glycopyrrolate
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: glycopyrronium bromide
CAS Number: 596-51-0
Current Sponsor code: NVA237
Con
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female adults aged 40 years or older. •Patients with moderate to severe COPD according to the GOLD Guidelines (2006) •Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc. •Patients with a post-bronchodilator FEV1 equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2. Predicted normal FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH (1993)] (for details see Section 10 and Appendix 4) •Written informed consent by the patient prior to initiation of any study-related procedure. (Study related procedures include the washout of inhaled beta 2-agonists, including the beta 2-agonist component of fixed dose combinations of inhaled beta 2-agonists and inhaled corticosteroids, prior to FEV1 measurements at visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period •Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period 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 •Patients with a history of asthma indicated by;blood eosinophil count > 400/mm3, Onset of symptoms prior to age 40 years. •Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged. •Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. •Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. •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. Other medications / therapies •Patients contraindicated for salbutamol treatment or who have shown an untoward reaction to inhaled anticholinergic agents. •Patients who need the treatments for COPD and allied conditions unless they have had the minimum washout prior to visit 2 specified below: •The long acting anticholinergic agent tiotropium: 7 days •Short acting anticholinergics: 8 hours •Fixed combinations of beta 2-agonists and inhaled corticosteroids: 48 hours •Long-acting beta 2-agonists: 48 hours •Short acting beta 2-agonists: 6 hours •Theophylline: 7 days •Combinations of inhaled anticholinergics and ß2 agonists: 24 hours Patients taking steroid / ß2-agonist fixed combinations prior to visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to visit 2. •Patients who need the following treatments for COPD and allied conditions unless they have been stabilized for at least one month prior to visit 1: •Inhaled or nasal corticosteroids •Cromoglycate, nedocromil, leukotriene antagonists in recommended and constant doses and dose regimens •Patients taking ß blocking agents Investigational drug / therapy use •Use of other investigational drugs at the time of enrollment , or within 30 days or 5 half-lives of enrollment, whichever is longer Ingredient hypersensitivity •History of hypersensitivity to any of the study drugs including rescue medication or to drugs with similar chemical structures Compliance / reliability / investigator’s judgment •Patients who are in the opinion of the investigator known to be unreliable, or non-compliant, or with any condition or prior or present treatment rendering the patient ineligible for the study. •Patients unable to use a dry powder inhaler (SDDPI) device or a pressurized MDI •Patients unable to perform spirometry measurements or complete a diary card. •
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety/tolerability of 28 days of treatment with NVA237 100 and 200µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD). ;Secondary Objective: To evaluate the bronchodilator efficacy of NVA237 compared to placebo over 28 days treatment in patients with moderate or severe COPD. The following assessment of efficacy will be based on the spirometric data collected during the study. •Mean trough FEV1 at Day 28 and Day 1 •FEV1 over time for all scheduled time points at 5, 15, 30 minutes, 1, 2, 3, 4, 5 hours post-dosing on Day 1, Day 14 and Day 28 •FVC over time for all scheduled time points at 5, 15, 30 minutes, 1, 2, 3, 4, 5 hours, 23 hours and 15 minutes, 23 hours and 45 minutes post-dosing on Day 1 and Day 28 and 5, 15, 30 minutes, 1, 2, 3, 4, 5 hours post-dosing at Day 14 •Peak FEV1 (defined as the maximum FEV1 value post-dosing) at Day 1 and Day 28 •Standardized (with respect to time) FEV1 AUC 5 minutes-5 hours post dose at Day 1, Day 14 and Day 28 To evaluate the effect of NVA237 compared to placebo over 28 days treatment on other clinical variables, i.e. clinical symptom and use of rescue medication. ;Primary end point(s): To primary objective is assess the safety/tolerability of 28 days of treatment with NVA237 100 and 200µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD). The assessment of safety will be based on all safety data collected during the study including vital signs, ECGs, laboratory evaluations, spirometry and adverse events. To assess tolerability particular attention will be paid in the analysis to adverse events associated with muscarinic antagonists including dry mouth, GI disturbances, increased pulse rate, blurred vision, glaucoma, urinary difficulty and urinary retention | — |
Countries
France, Germany, Spain
Outcome results
None listed