Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Phase 4CompletedNCT01922271

Novartis Pharmaceuticals152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

152

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

NVA237DRUG

NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)

TiotropiumDRUG

Tiotropium 18 μg once daily delivered via HandiHaler® device.

Placebo to NVA237DRUG

Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (14)

Novartis Investigative Site

Leipzig, Germany, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2

Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).

Time frame: Day 1

Secondary Outcomes

Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose

Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.

Time frame: Day 1

Specific Airway Resistance (sRAW)

Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa\*s. Whole body plethysmography (Bodybox) is used to measure SRaw.

Time frame: Day 1

Functional Resistance Capacity (FRCpleth)

Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).

Time frame: Day 1

Residual Volume (RV)

Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).

Time frame: Day 1

Total Lung Capacity (TLC)

Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.

Data from ClinicalTrials.gov

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