Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01699685 | Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide. | PHASE3 | COMPLETED | 79 | — | — | Nov 1, 2012 | Jun 1, 2014 | Feb 9, 2016 | 11 | Switzerland |
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).
| Arm | Type | Description |
|---|---|---|
| Sequence A | PLACEBO_COMPARATOR | Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI |
| Sequence B | ACTIVE_COMPARATOR | Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI |
| Name | Type | Description |
|---|---|---|
| QAB149 | DRUG | Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI |
| Placebo | DRUG | Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI |
| NVA237 | DRUG | Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI |
Inclusion criteria: * Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack year history of smoking * FEV1 \<80% and ≥30% of the predicted normal value who ...