Pulmonary Gas Exchange Response to Indacaterol in COPD

NCT02547558 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-09-11

No results posted yet for this study

Summary

To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups.

Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.

Conditions

Interventions

PROCEDURE

Arterial blood gases

Measured through radial arterial catheter

PROCEDURE

Cardiac Output

Measured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display.

PROCEDURE

Vital signs

As measured in clinical practice

PROCEDURE

Exhaled breath

Were recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.).

PROCEDURE

Spirometry

In a daily calibrated spirometer.

DRUG

Indacaterol

Indacaterol Breezhaler@ 300 mcg (1 inhalation)

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Isabel Blanco, MD, PhD · Hospital Clínic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Spain

Study Locations

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Entities

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 NCT02547558 on ClinicalTrials.gov