Phase 3
Completed N=441
NVA237 Versus Placebo 12-week Efficacy Study
Source: ClinicalTrials.gov NCT01709864 ↗Enrolled (actual)
441
Serious AEs
5.3%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing — 0.125; -0.014 liters*hr
Summary
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 will be tested against a placebo treatment.
The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing |
0.125; -0.014 | — |
| SECONDARY Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit |
0.141; 0.025; 0.123; 0.007; 0.112; -0.002 | — |
| SECONDARY Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85) |
0.140; -0.001; 0.174; 0.021; 0.171; 0.001 | — |
| SECONDARY Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire |
-4.4; -1.7 | — |
| SECONDARY Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12 |
49.0; 40.6 | — |
| SECONDARY Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12 |
1.46; 0.54 | — |
| SECONDARY Change From Baseline of Daily Symptom Scores |
-1.39; -1.01 | — |
| SECONDARY Change From Baseline of Morning and Nighttime Symptom Scores at Week 12 |
-1.14; -0.73; -1.22; -0.95 | — |
| SECONDARY Percentage of Nights With "no Nighttime Awakenings" |
13.3; 11.3 | — |
| SECONDARY Percentage of Days With "no Daytime Symptoms" |
5.1; 2.5 | — |
| SECONDARY Percentage of "Days Able to Perform Usual Daily Activities" |
8.6; 1.8 | — |
| SECONDARY The Average Number of Puffs of Rescue Medication Per Day |
-1.63; -0.86 | — |
| SECONDARY Percentage of Days Without Rescue Medication Use |
16.6; 10.5 | — |
| SECONDARY Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85) |
0.175; 0.037; 0.265; 0.044; 0.318; 0.032 | — |
| SECONDARY Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85) |
0.074; 0.015; 0.129; 0.015; 0.176; 0.008 | — |
Eligibility Criteria
Inclusion criteria
- Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011).
- Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.
- Current or ex-smokers with at least 10 cigarette pack years smoking history.
Exclusion criteria
- Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
- Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
- Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
- Patients with a body mass index (BMI) of more than 40 kg/m2.
- Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
- Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01709864). 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.