MedTrace Logo

The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.

NCT02914652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-07-05

No results posted yet for this study

Summary

The overall objective for this study is to test whether β2-agonists will affect the cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.

Conditions

  • Ventricular Septal Defect

Interventions

DRUG

Salbutamol

Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.

DRUG

Norflouran (Placebo Evohaler(R) )

Placebo Evohaler(R) MDI, inhalation spray, 60 mg/dose, 9 doses administered as coherent single doses.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Vibeke E Hjortdal, MD PhD DMSc · Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-15
Primary Completion
2017-07-01
Completion
2018-01-01

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT02914652 on ClinicalTrials.gov