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Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01019694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2014-10-23

Study results available
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Summary

The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Combivent CFC-MDI

36/206 mcg Four times a day (QID)

DRUG

Combivent Respimat 20/100 mcg

Open label randomized parallel

DRUG

Atrovent HFA 42 mcg + Albuterol HFA 200 mcg

Open label randomized parallel

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01019694 on ClinicalTrials.gov