Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Seebri Breezhaler
Product Name: Glycopyrronium bromide 44 µg (of active moiety delivered) or 50 µg (of active moiety in the capsule)
Product Code: NVA237
Pharmaceutical Form: Inhalation po
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent must be obtained before any assessment is performed. •Male and female adults aged =40 years •Patients with stable COPD according to the current GOLD strategy (GOLD 2014). •Current or ex-smokers who have a smoking history of at least 10 pack years. An ex-smoker may be defined as a subject who has not smoked for = 6 months at screening. •mMRC grade of at least 2 at Visit 101. •Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30 % and =65 years) yes F.1.3.1 Number of subjects for this age range 376
Exclusion criteria
Exclusion criteria: •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 hCG laboratory test. •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. •Patients with Type I or uncontrolled Type II diabetes. •Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for females) and confirmed by a central assessor. •Patients requiring long term oxygen therapy prescribed for >12 h per day. •Patients with any history of asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12;Secondary Objective: ?Standardized Area Under The Curve (AUC) for Forced Expiratory Volume in one second (FEV1) for different time spans(0-24h, 0-12h, 12-24h) post dosing at Week 12 ?Health Status Assessment by St. George's Respiratory Questionnaire (SGRQ) after 12-and 26-week treatment ?Breathlessness assessed by Transition Dyspnea Index (TDI) after 12 and 26 weeks treatment ?Trough Forced Expiratory Volume in one second (FEV1) at Day 1 and Week 26 ?Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing at Week 26 ?Forced Vital Capacity (FVC) at individual timepoints throughout treatment period ?Forced Expiratory Volume in one second (FEV1) at all individual timepoints throughout treatment period ?Inspiratory Capacity (IC) at individual timepoints throughout treatment period ?Rescue medication use ?Daily Symptom Score ?Safety and Tolerability ?Standardized AUC for Forced Expiratory Volume in one second (FEV1) post dosing on Day 1;Primary end point(s): Trough Forced Expiratory Volume in 1 second (FEV1) (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose);Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary endpoints, the degree of bronchodilation produced by the once and twice daily therapies over 24 hours will be measured in terms of post dose FEV1 AUC0-24h at week 12 and week 26; differences between the therapies in the level of bronchodilation produced in the morning and evening/ overnight will be assessed in terms of FEV1 AUC0- 12h and FEV1 AUC12-24h. In addition, to determine the impact of dosing regimen on the degree of bronchodilation immediately prior to dosing in the morning, assessments of pre dose trough FEV1 will be performed at Day 1, Week 12 and Week 26.;Timepoint(s) of evaluation of this end point: day 1, week 12 and week 26 | — |
Countries
Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Poland, Romania, Russian Federation, Sweden, United Kingdom
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed