MedTrace Logo

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

NCT01922271 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-01-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

NVA237

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

DRUG

Tiotropium

Tiotropium 18 μg once daily delivered via HandiHaler® device.

DRUG

Placebo to NVA237

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

DRUG

Placebo to tiotropium

Placebo to tiotropium once daily delivered via HandiHaler® device

DRUG

Salbutamol

Used as resuce medication

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922271 on ClinicalTrials.gov