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

NCT01865500 | Completed Phase 4

• 1 other identifier: EUcar
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

COPD exacerbation; Nebulized budesonide; Parenteral steroid

Outcome Measures

Primary Outcomes (1)

• change of arterial blood gases from H0 to H24, H48 and before discharge

  Participants will be followed for the duration of hospital stay, an expected average of 10 days.

Secondary Outcomes (1)

• Changes in FEV1 (forced expiratory volume in 1 second), dyspnea score.

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Other Outcomes (1)

• Hospitalization duration

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (3)

Metil prednisolone & Budesonide 4mg

ACTIVE COMPARATOR

Drug: Budesonide 4 mg; Drug: Metil prednisolone

Metil prednisolone & Budesonide 8 mg

ACTIVE COMPARATOR

Drug: Budesonide 8 mg; Drug: Metil prednisolone

Budesonide 4 mg & Budesonide 8 mg

ACTIVE COMPARATOR

Drug: Budesonide 4 mg; Drug: Budesonide 8 mg

Interventions

Budesonide 4 mg DRUG

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

Budesonide 4 mg & Budesonide 8 mg; Metil prednisolone & Budesonide 4mg

Budesonide 8 mg DRUG

Baseline FEV1 and before discharge FEV1 were evaluated

Budesonide 4 mg & Budesonide 8 mg; Metil prednisolone & Budesonide 8 mg

Metil prednisolone DRUG

Metil prednisolone & Budesonide 4mg; Metil prednisolone & Budesonide 8 mg

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate or severe COPD exacerbation who are older than 40-years-old
• A smoking history of at least 10-pack-years
• Requiring hospitalization because of COPD exacerbation

You may not qualify if:

• Presence of asthma, allergic rhinitis, atopy or any systemic disease (such as diabetes mellitus or hypertension)
• Exposed to systemic corticosteroids in the preceding month or used more than 1,500 microg/d of inhaled beclomethasone equivalent
• Admission to the intensive care unit (pH\<7.30 and/or PaCO2 \> 70 mm Hg, and/or PaO2 \< 50 mm Hg despite supplemental oxygen)
• If a specific cause for the exacerbation, such as pneumonia, pneumothorax, or heart failure, was diagnosed.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Faculty of Medicine Pulmonary Disease Department

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (3)

• Maltais F, Ostinelli J, Bourbeau J, Tonnel AB, Jacquemet N, Haddon J, Rouleau M, Boukhana M, Martinot JB, Duroux P. Comparison of nebulized budesonide and oral prednisolone with placebo in the treatment of acute exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2002 Mar 1;165(5):698-703. doi: 10.1164/ajrccm.165.5.2109093.

  PMID: 11874817 BACKGROUND

• Gaude GS, Nadagouda S. Nebulized corticosteroids in the management of acute exacerbation of COPD. Lung India. 2010 Oct;27(4):230-5. doi: 10.4103/0970-2113.71957.

  PMID: 21139721 BACKGROUND

• Gunen H, Mirici A, Meral M, Akgun M. Steroids in acute exacerbations of chronic obstructive pulmonary disease: are nebulized and systemic forms comparable? Curr Opin Pulm Med. 2009 Mar;15(2):133-7. doi: 10.1097/MCP.0b013e32832185da.

  PMID: 19532028 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Disease

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

TU (1)