MedTrace Logo

A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD

NCT02276222 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1087

Last updated 2018-03-13

Study results available
· View outcomes & findings →

Summary

This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

SUN-101 50 mcg BID eFlow (CS) nebulizer

SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer

DRUG

Spiriva® 18 mcg QD Handihaler

Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Sponsors & Collaborators

  • Sunovion Respiratory Development Inc.

    lead INDUSTRY

Principal Investigators

  • Respiratory Medical Director · Sunovion Respiratory Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Czechia
  • Hungary
  • Russia

Study Locations

More Related Trials

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 NCT02276222 on ClinicalTrials.gov