MedTrace Logo

Two Different Dosages of Nebulized Steroid Versus Parenteral Steroid in the Management of COPD Exacerbations

NCT01865500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-05-31

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) is a common disease that has a chronic and progressive course. Patients with COPD may have exacerbations one to four times in a year. Numbers of exacerbations are important because of increased morbidity and mortality and healthcare costs.

Systemic corticosteroids (SC) are recommended in the management of exacerbations of COPD as well as bronchodilator, oxygen and antibacterial treatment by all international guidelines. However, there are still some concerns about systemic corticosteroid use because COPD patients are older and relatively immobilized. In addition, exacerbation rate is significantly higher in a group of COPD patients, and these patients need higher amounts of SC in order to control of exacerbation. It results in some adverse effects such as osteoporosis and bone fractures, thinning of the skin, posterior subcapsular cataract formation, glucose intolerance and myopathy. Thus, this condition leads clinicians to seek alternative options. However, there are few studies showing that nebulized steroids (NS) are as effective as SC in exacerbations of COPD and the optimal NS dose is not certain.

The investigators aimed to determine the optimal NS dose and evaluate the efficacy and safety of NS compared with SC in the treatment of patients with COPD exacerbations requiring hospitalization.

Conditions

Interventions

DRUG

Budesonide 4 mg

It will be evaluated at baseline, 24 h, 48 h and before discharge

DRUG

Budesonide 8 mg

Baseline FEV1 and before discharge FEV1 were evaluated

DRUG

Metil prednisolone

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT01865500 on ClinicalTrials.gov