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Phase IV O2 Consumption Study in COPD Patients.

NCT02533505 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-07-30

Study results available
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Summary

A Phase IV study evaluating changes in oxygen consumption and cardiac function in Subjects with Chronic obstructive pulmonary disease (COPD) with resting hyperinflation after administration of Symbicort pMDI 160/4.5 μg.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol

Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints

DRUG

Matching Placebo pMDI 160/4.5 μg

Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-25
Primary Completion
2016-08-12
Completion
2016-08-12

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 NCT02533505 on ClinicalTrials.gov