Phase 2
Completed N=388
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01119950 ↗Enrolled (actual)
388
Serious AEs
2.6%
Results posted
Apr 2014
Primary outcomePrimary: Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28 — 27.1; 42.0; 61.6; 58.5 Percentage of maximal response
Summary
This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28 |
27.1; 42.0; 61.6; 58.5; 75.5; 73.0 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237 |
0.037; 0.037; 0.036; 0.035; 0.034; 0.033 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment |
28.9; 44.8; 49.0; 61.9; 65.7; 76.4 | — |
| SECONDARY Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment |
0.008; 0.008; 0.008; 0.008; 0.008; 0.008 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28 |
50.8; 66.9; 58.9; 79.7; 73.7; 88.3 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment |
27.1; 42.7; 35.5; 59.8; 52.4; 74.9 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment |
53.3; 69.2; 61.1; 81.5; 75.6; 89.6 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment |
23.3; 37.4; 53.6; 54.0; 69.3; 69.7 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14 |
28.5; 43.8; 63.3; 60.1; 76.7; 74.3 | — |
| SECONDARY Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment |
38.3; 55.4; 59.5; 71.3; 74.6; 83.2 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment |
58.4; 73.2; 66.1; 84.1; 79.1; 91.1 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14 |
54.2; 70.3; 63.6; 82.6; 77.8; 90.5 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment |
49.5; 66.2; 58.8; 79.6; 74.1; 88.7 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment |
23.9; 37.9; 54.4; 54.1; 69.5; 69.3 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment |
35.1; 52.0; 44.4; 68.4; 61.5; 81.2 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment |
61.7; 76.0; 68.9; 86.1; 81.3; 92.3 | — |
| SECONDARY Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14 |
22.8; 36.8; 52.9; 53.4; 68.7; 69.1 | — |
| SECONDARY Mean Daily Use of Rescue Medication by Treatment at Different Time Points |
4.16; 4.16; 3.83; 4.45; 3.47; 4.81 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients age 40 years or more
- Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
- Smoking history of at least 10 pack-years
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) 600/mm3 or onset of symptoms prior to 40 years
- Patients with eczema, known high IgE levels or a known positive skin prick test
- Patients participating in the active phase of a pulmonary rehabilitation programme
- Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
- Patients with a history of alpha-1 anti-trypsin deficiency
- Patients on long term oxygen therapy (>15hr per day)
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01119950). 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.