Phase 4
Completed N=152
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01922271 ↗Enrolled (actual)
152
Serious AEs
1.3%
Results posted
Jan 2015
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2 — 1.490; 1.453 liters per hour
Summary
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2 |
1.490; 1.453 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose |
1.433; 1.398 | — |
| SECONDARY Specific Airway Resistance (sRAW) |
4.203; 4.105; 2.904; 3.089; 2.656; 2.877 | — |
| SECONDARY Functional Resistance Capacity (FRCpleth) |
5.211; 5.142; 4.823; 4.852; 4.769; 4.725 | — |
| SECONDARY Residual Volume (RV) |
4.433; 4.344; 3.996; 4.035; 3.891; 3.913 | — |
| SECONDARY Total Lung Capacity (TLC) |
7.380; 7.335; 7.255; 7.274; 7.224; 7.161 | — |
| SECONDARY Inspiratory Capacity (IC) |
2.169; 2.193; 2.433; 2.422; 2.455; 2.435 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 years
- Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Exclusion Criteria
- Pregnant or nursing (lactating) women
- Patients who have a clinically significant laboratory abnormality at run-in
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
- Patients with any history of asthma
- Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
- Patients receiving medications in the classes listed in the protocol as prohibited.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01922271). 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.