Phase 4
Completed N=776
A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
Source: ClinicalTrials.gov NCT02371629 ↗Enrolled (actual)
776
Serious AEs
8.1%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 — 0.092; 0.059 Liters — p=0.051
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
0.092; 0.059 | 0.051 |
| SECONDARY Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 12 |
0.136; 0.106; 0.085; 0.043; 0.035; -0.019 | — |
| SECONDARY Change From Baseline in Area Under The Curve (AUC 0-12 Hour) for Forced Expiratory Volume in One Second (FEV1) Post Dosing at Day 1 |
0.143; 0.139 | — |
| SECONDARY Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 26 |
0.123; 0.091; 0.076; 0.030; 0.032; -0.028 | — |
| SECONDARY Change From Baseline in Total St. George's Respiratory Questionnaire (SGRQ) Score at Week 12 and Week 26 |
-5.320; -3.563; -6.587; -4.644 | — |
| SECONDARY Percentage of Patients With a Clinically Significant Improvement in St George Respiratory Questionnaire at Week 12 and Week 26 |
54.5; 46.9; 59.4; 49.6 | — |
| SECONDARY Change From Baseline in Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26 |
1.346; 0.849; 1.523; 1.170 | — |
| SECONDARY Percentage of Patients With a Clinically Important Improvement on Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26 |
56.9; 52.0; 61.1; 54.6 | — |
| SECONDARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 26 |
0.119; 0.070; 0.104; 0.056 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Individual Timepoints at Week 26 |
0.079; 0.025; 0.102; 0.029; 0.159; 0.085 | — |
| SECONDARY Change From Baseline in Inspiratory Capacity (IC) at Individual Timepoints at Week 26 |
0.094; 0.054; 0.181; 0.173; 0.193; 0.171 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Individual Timepoints at Week 26 |
0.058; 0.012; 0.086; 0.034; 0.111; 0.070 | — |
| SECONDARY Change From Baseline in the Percentage of Days With no Rescue Medication Use Over the 26 Weeks |
16.574; 15.363 | — |
| SECONDARY Change From Baseline in Mean Daily COPD Symptom Score at Week 26 |
-1.336; -1.107; -1.032; -0.828; -1.205; -1.056 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Death |
203; 224; 33; 30; 1; 1 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT02371629). 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.