Phase 3
Completed N=432
NVA237 BID Versus Placebo Twelve-week Efficacy Study
Source: ClinicalTrials.gov NCT01715298 ↗Enrolled (actual)
432
Serious AEs
3.3%
Results posted
Mar 2015
Primary outcomePrimary: Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing — 0.115; -0.008 Liters
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 in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing |
0.115; -0.008 | — |
| SECONDARY Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing |
0.121; 0.003 | — |
| SECONDARY Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing |
0.154; 0.014; 0.153; 0.004; 0.118; 0.011 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints |
4.9; -0.3; 9.9; 0.3; 13.9; 1.2 | — |
| SECONDARY Mean Trough Forced Expiratory Volume in One Second |
0.128; 0.021; 0.123; 0.038 | — |
| SECONDARY Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire |
-6.4; -1.2 | — |
| SECONDARY Breathlessness Assessed by Transition Dyspnea Index |
0.95; 0.48 | — |
| SECONDARY Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day |
-1.33; -0.80 | — |
| SECONDARY Change From Baseline in the Percentage of Days Without Rescue Medication Use |
11.4; 7.0 | — |
| SECONDARY Change From Baseline in Daily Symptom Scores |
-1.09; -0.80 | — |
| SECONDARY Change From Baseline in the Percentage of Nights With "no Nighttime Awakenings" |
13.1; 9.2 | — |
| SECONDARY Change From Baseline in the Percentage of Days With "no Daytime Symptoms" |
3.6; 2.6 | — |
| SECONDARY Change From Baseline in Percentage of "Days Able to Perform Usual Daily Activities" |
5.2; 0.9 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity at All Individual Timepoints |
0.120; -0.014; 0.233; 0.005; 0.304; 0.041 | — |
| SECONDARY Change From Baseline in Mean Trough Forced Vital Capacity |
0.249; 0.078; 0.210; 0.080 | — |
| SECONDARY Change From Baseline in Morning and Nighttime Symptom Scores |
-0.86; -0.61; -1.03; -0.76 | — |
Eligibility Criteria
Inclusion criteria: 1. 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). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/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-defnied inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01715298). 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.