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Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)

NCT01488019 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1071

Last updated 2017-06-12

Study results available
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Summary

This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.

Conditions

Interventions

DRUG

Perforomist-Placebo

Placebo vehicle, 2mL, twice daily for 52 weeks

DRUG

Perforomist, nebulization, COPD

Perforomist, 20 mcg/2 mL, twice daily for 52 weeks

Sponsors & Collaborators

  • Dey

    lead INDUSTRY

Principal Investigators

  • Dik Ng · Mylan Pharma UK Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01488019 on ClinicalTrials.gov