Phase 3
Completed N=78
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
Source: ClinicalTrials.gov NCT01699685 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Inspiratory Capacity (IC) Peak Value — 2.87; 2.94; 2.99; 2.85 Liters
Summary
The study purpose is to evaluate the effect of QAB149
* NVA237 vs. QAB149 on static lung hyperinflation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inspiratory Capacity (IC) Peak Value |
2.87; 2.94; 2.99; 2.85 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) |
1.49; 1.57; 1.50; 1.60; 1.51; 1.60 | — |
| SECONDARY Inspiratory Capacity (IC) |
2.67; 2.75; 2.67; 2.79; 2.69; 2.71 | — |
| SECONDARY Forced Volume Capacity (FVC) |
2.98; 3.00; 3.00; 3.02; 3.01; 3.04 | — |
| SECONDARY Total Lung Capacity (TLC) |
7.20; 6.81; 7.17; 6.79; 7.06; 6.81 | — |
| SECONDARY Airway Resistance (Raw) |
5.13; 4.74; 5.19; 4.61; 5.21; 4.43 | — |
Eligibility Criteria
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 have signed an informed consent form prior to the initiation of any study-related procedure
Exclusion criteria
- No COPD exacerbations within 6 weeks prior to dosing
- No concomitant lung disease such as asthma
- Nno requirement for long term oxygen treatment or history of lung reduction surgery
- No medical conditions that would interfere with the performance of spirometry
- No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.
Data sourced from ClinicalTrials.gov (NCT01699685). 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.