Chronic obstructive pulmonary disease (COPD) MedDRA version: 12.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Glycopyrrolate
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596510
Other descriptive name: Glycopyrro
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following 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 (Stage II or Stage III) according to the GOLD Guidelines 2008. 3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) 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: General exclusion 1. Pregnant women or nursing mothers (pregnancy confirmed by 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, OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy), OR are using one or more of the following acceptable methods of contraception: • surgical sterilization (e.g., bilateral tubal ligation), • double barrier method (diaphragm plus condom) • hormonal contraception (implantable, patch, oral, IM), and copper coated IUD), if accepted by local regulatory authority and ethics committee • At the discretion of the investigator, total abstinence is acceptable in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance • Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. NOTE: Reliable contraception should be maintained throughout the study 3. Patients who have a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients should not be re-screened). 4. Patients with a history of long QT syndrome or whose QTc measured at Visit 2 (Day -7) (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by a central ECG assessor. 5. Patients with Type I or uncontrolled Type II Diabetes. 6. 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, history of myocardial infarction, arrhythmia (excluding chronic stable AF) • 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. • narrow-angle glaucoma • symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention • uncontrolled hypo- or hyperthyroidism, hypokalemia, or hyperadrenergic state • any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 7. 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 beta-2 agonists • sympathomimetic amines. COPD specific exclusion 8. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at Visit 2), or onset of symptoms prior to age 40 years. 9. Patients with eczema, known high IgE levels or a known positive skin prick test. 10. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by x-ray to be no longer active), clinically significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the maximal effect of NVA237. (Trough is defined as the mean of FEV1 measurements at 23 h 15 min and 23 h 45 min post morning dose). ;Secondary Objective: Key secondary objective To evaluate the magnitude of any difference of effect on trough FEV1 after 28 days of treatment between the same total daily doses of NVA237 by comparing once daily and twice daily dosing regimens. Important secondary objectives • To evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on AUC5 min-24 h FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the maximal effect of NVA237. • To evaluate the magnitude of any difference of effect on AUC5 min-24 h FEV1 after 28 days of treatment between the same total daily doses of NVA237 by comparing once daily and twice daily dosing regimens. ;Primary end point(s): To evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the maximal effect of NVA237. (Trough is defined as the mean of FEV1 measurements at 23 h 15 min and 23 h 45 min post morning dose). | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed