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Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

NCT01959516 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2016-04-15

Study results available
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Summary

This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD symptoms and ability to perform daily activities by the patient.

Conditions

Interventions

DRUG

Glycopyrronium

Glycopyrronium capsule for inhalation once per day via SDDPI

DRUG

Tiotropium

Tiotropium capsule for inhalation once per day via HandiHaler® device

DRUG

Placebo to glycopyrronium

Placebo to glycopyrronium capsule for inhalation once per day via SDDPI

DRUG

Placebo to tiotropium

Placebo to tiotropium capsule for inhalation once per day via HandiHaler® device

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT01959516 on ClinicalTrials.gov