Phase 3
Completed N=1,066
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00929110 ↗Enrolled (actual)
1,066
Serious AEs
14.0%
Results posted
Jul 2012
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 — 1.469; 1.372; 1.455 Liters
Summary
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
1.469; 1.372; 1.455 | — |
| SECONDARY Transition Dyspnea Index (TDI) at Week 26 |
2.13; 1.32; 2.26 | — |
| SECONDARY Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52 |
40.85; 44.16; 41.32 | — |
| SECONDARY Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) |
363.0; 231.0; 364.0 | — |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52) |
-1.58; -1.20; -1.83 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52 |
1.478; 1.388; 1.471; 1.458; 1.324; 1.408 | — |
| SECONDARY Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52 |
2.936; 2.757; 2.930; 2.985; 2.802; 2.970 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 |
1.494; 1.416; 1.447; 1.548; 1.428; 1.485 | — |
| SECONDARY Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 |
3.027; 2.826; 2.956; 3.050; 2.802; 2.991 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 |
1.443; 1.357; 1.402; 1.501; 1.359; 1.437 | — |
| SECONDARY Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52 |
2.915; 2.731; 2.856; 2.982; 2.719; 2.903 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52 |
1.570; 1.373; 1.514; 1.560; 1.384; 1.531 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52 |
1.566; 1.407; 1.534; 1.539; 1.398; 1.505 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52 |
1.486; 1.380; 1.459; 1.445; 1.339; 1.379 | — |
| SECONDARY Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52) |
0.54; 0.80; 0.62 | — |
| SECONDARY Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52) |
32.8; 40.2; 30.1 | — |
| SECONDARY Percentage of Nights With "no Nighttime Awakenings" During the Study (Baseline to Week 52) |
57.36; 52.15; 55.47 | — |
| SECONDARY Percentage of Days With "no Daytime Symptoms" During the Study (Baseline to Week 52) |
6.54; 3.81; 7.14 | — |
| SECONDARY Percentage of "Days Able to Perform Usual Daily Activities" During the Study (Baseline to Week 52) |
38.02; 36.18; 38.09 | — |
| SECONDARY Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52) |
-1.85; -1.42; -1.87 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
- Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and 15 h a day) 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 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
- Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
- Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
- Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (> 450 ms for males or > 470 ms for females.
Other protocol-defined inclusion/exclusion criteria may apply to the study.
Data sourced from ClinicalTrials.gov (NCT00929110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.