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A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

NCT02371629 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2019-08-09

Study results available
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Summary

This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.

Conditions

Interventions

DRUG

NVA237

NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1

DRUG

Placebo

Placebo to NVA237

DRUG

Salbutamol

All patients received salbutamol (100 μg) as only rescue medication

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-24
Primary Completion
2016-11-16
Completion
2016-11-16

Countries

  • Belgium
  • Bulgaria
  • Finland
  • Germany
  • Hungary
  • Israel
  • Poland
  • Romania
  • Russia
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT02371629 on ClinicalTrials.gov