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Comparison of Safety and Efficacy of COMBIVENT HFA to COMBIVENT (CFC) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02194205 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-07-18

No results posted yet for this study

Summary

To compare the long-term (one-year) bronchodilator efficacy and safety of COMBIVENT hydrofluoroalkane (HFA) Inhalation Aerosol to COMBIVENT chlorofluorocarbon (CFC) Inhalation Aerosol and Placebo formulations of each in patients with COPD. In addition, steady state pharmacokinetics over one dosing interval following four weeks of therapy will be characterized.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

COMBIVENT HFA

DRUG

Placebo HFA

DRUG

COMBIVENT CFC

DRUG

Placebo CFC

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2001-06-30

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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 NCT02194205 on ClinicalTrials.gov