Phase 3
Completed N=657
Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01613326 ↗Enrolled (actual)
657
Serious AEs
3.7%
Results posted
Apr 2014
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) — 1.405; 1.405 Liters
Summary
This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) |
1.405; 1.405 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority) |
1.398; 1.393 | — |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment |
2.209; 2.086; 1.990; 2.178 | — |
| SECONDARY St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment |
39.42; 38.77 | — |
| SECONDARY Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment |
4.09; 4.10; 2.76; 2.84 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4 |
1.385; 1.386; 1.416; 1.416 | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) During 5 Min to 4 Hours Post-dose, at Day 1 and Week 12 |
1.575; 1.520; 1.577; 1.553 | — |
| SECONDARY Inspiratory Capacity (IC) at Each Time-point, by Visit |
2.378; 2.300; 2.433; 2.335; 2.343; 2.309 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) at Each Time-point by Visit |
1.382; 1.331; 1.428; 1.365; 1.442; 1.379 | — |
| SECONDARY Forced Vital Capacity (FVC) at Each Time-point by Visit |
2.925; 2.874; 3.004; 2.954; 3.036; 2.991 | — |
| SECONDARY Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (5 Min-4 h) Post-dose |
1.496; 1.438; 1.493; 1.470 | — |
| SECONDARY Event Free Rate at Weeks 4, 8 and 12 After Treatment |
95.6; 96.6; 92.9; 93.8; 90.2; 92.4 | — |
| SECONDARY Mean Daily, Daytime and Nighttime (Combined) Symptom Scores Over the 12 Week Treatment Period |
7.21; 6.90; 5.96; 5.96 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD 2010).
- Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥ 30% and < 80% of the predicted normal, and a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.70 at screening
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs).
- Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
Exclusion Criteria
- Pregnant or nursing (lactating) women
- Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1.
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered).
- Patients receiving medications in the classes listed in the protocol as prohibited.
Other protocol-defined inclusion/exclusion criteria apply and can be found in the study protocol
Data sourced from ClinicalTrials.gov (NCT01613326). 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.