None listed
Conditions
Interventions
Group 1 Type of group
Patients inhaled NVA237 50 μ
g once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable througho
Patients inhaled tiotropium 18 μ
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
40 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female adults> 40 years of age, who have signed an Informed Consent Form before the start of any procedure related to the study. • Patients with moderate to severe stable COPD (Stage II or Stage III) in accordance with the GOLD 2008 Guidelines. • Current smokers or former smokers who have a smoking history of at least 10 packages per year. (Ten packages per year are defined as 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, etc.) • Patients with a post-bronchodilator FEV1> 30% and <80% of the normal predictive, and a post-bronchodilator FEVVFVC <0.7 at Visit 2 (day * 14) • Patients with, according to electronic journal data between Visit 2 (-14) and Visit 3 (day 1), a total score of 1 or more in at least 4 of the 7 days prior to Visit 3 (For information on score see Section 7.4,3,1.)
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding women (pregnancy confirmed with a positive urine pregnancy test). • Women with reproductive potential, unless they use an approved method of medical or surgical contraception. • Patients who require long-term oxygen therapy (> 15 h per day) daily for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airway disease in the 6 weeks prior to Visit 1 or between Visit 1 ( day -21) and Visit 3 (day 1). • Patients who have had an infection of the lower respiratory tract within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or an exacerbation of COPD during the selection period (until Visit 3 (day 1)) will not be eligible, but will be allowed to be re-selected later (at least 6 weeks). after resolution of the lower respiratory tract infection) • Patients who, in the opinion of the researcher or staff responsible for Novartis, have a clinically relevant laboratory abnormality or a clinically significant condition • Patients with a history of asthma, suggested by (among others, but not in a restrictive way) a blood eosinophil count> 600 / mm3 (at visit 1) or a start of symptoms before the age of 40 • Patients with a history of prolonged QT syndrome or whose QTc measured on Visit 1 (day -21) (Fridericia Method) is prolonged (> 450 ms for men or> 470 for women). • Treatments for COPD and associated conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates. Measure:Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure. Measure:Transition Dyspnea Index (TDI) at Week 26 Timepoints:Week 26 ; Outcome name:The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure. Measure:Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 Timepoints:Week 52 ; Outcome name:Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required. Measure:Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) Timepoints:Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks) | — |
Countries
Argentina, Canada, Chile, France, Germany, Hungaria, Israel, Italy, Korea South, Mexico, Netherlands, New Zealand, Peru, Poland, Russian Federation, United States
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed