Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
Product Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
Product Code: NVA237
Pharmaceutical Form: In
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female adults aged = 40 years. •Co-operative outpatients with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to GOLD criteria 2013 and including all of the following: a) Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has not smoked for = 6 months at Screening. b) Patients with airflow limitation indicated by a post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: •Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to Visit 1. In the event of an exacerbation occurring during the Screening period (Visits 1-2), the patient must be discontinued from the study. The patient may be re-enrolled once the inclusion/exclusion criteria are met. Only one re-enrollment is allowed. •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 permitted to re-enrol at a later date once the inclusion/exclusion criteria have been met. Only one re-enrollment is allowed. •Patients on any long-acting bronchodilator therapy. Those patients may enter the study after bronchodilator withdrawal during a 10-day wash-out period (only rescue salbutamol allowed as bronchodilator therapy during wash-out). Patients on fixed combination of long acting ß2-agonists/inhaled corticosteroid (LABA/ICS) therapy before screening must be switched to the equivalent dose of ICS monotherapy and salbutamol as rescue. •Patients receiving any other prohibited COPD-related medications specified in Table 5-1 must undergo the required wash-out period prior to Visit 2. •Patients who have had a clinical history of asthma. •Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis or clinically significant bronchiectasis. •Patients with alpha-1-antitrypsin deficiency. •Patients with contraindications for LAMA treatment including medical history of symptomatic prostatic hypertrophy, bladder neck obstruction, narrow-angle glaucoma and severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2) documented in the previous 6 months. •Patients with a history of unstable cardiovascular disease or arrhythmias including atrial fibrillation/flutter or long QT syndrome or whose resting QTcF (calculated according to Fridericia QT correction formula preferred, but Bazett acceptable) is prolonged (= 450 msec for males and = 460 msec for females) at screening (Visit 1) or baseline (Visit 2, baseline 1). •Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study. •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: -anticholinergic agents - long and short acting 2 agonists -sympathomimetic amines -excipients of the trial medication (lactose monohydrate and/or magnesium estearate) •Patients whose body mass index (BMI) is less than 15 or greater than 40 kg/m2. •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that glycopyrronium QD is superior to tiotropium QD in terms of FEV1 AUC0-4h after first dose of treatment.;Secondary Objective: To compare glycopyrronium QD versus tiotropium QD on symptoms, through the PRO-Morning COPD Symptoms Questionnaire measurement in the morning at 3 hours post inhalation on Day 1 and Week 4 of treatment.;Primary end point(s): Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on day 1 and week 4 of study treatment.;Timepoint(s) of evaluation of this end point: The assessment to address the primary objective will be performed at the start of both treatment epochs, i.e. first day of each treatment period (Day 1 and Day 43). All patients will be followed up (by telephone) 30 days after the last administration of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment.;Timepoint(s) of evaluation of this end point: The comparisons will be performed between results obtained at Day 1 (baseline, V2 and V5) and W4 (V4 and V7, end of treatment) of each treatment line. | — |
Countries
Germany, Italy, Spain, United Kingdom
Contacts
Public ContactMedical Competence Center
Novartis Pharma GmbH, Medizinischer Infoservice
Outcome results
None listed