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

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ClinicalTrials.gov Identifier: NCT01865500
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Elif Yilmazel Ucar, Ataturk University

Tracking Information
First Submitted Date  ICMJE May 20, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
change of arterial blood gases from H0 to H24, H48 and before discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Changes in FEV1 (forced expiratory volume in 1 second), dyspnea score. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2013)
Hospitalization duration [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Two Different Dosages of Nebulized Steroid Versus Parenteral Steroid in the Management of COPD Exacerbations
Official Title  ICMJE Not Provided
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.

Detailed Description

Study Population One hundred twenty patients with moderate or severe COPD exacerbation who are older than 40-years-old, had a smoking history of at least 10-pack-years and requiring hospitalization were included in the study. COPD diagnosis was based on clinical evaluation as defined by the American Thoracic Society (ATS). The patients were excluded if they had a presence of asthma, allergic rhinitis, atopy or any systemic disease (such as diabetes mellitus or hypertension); were exposed to systemic corticosteroids in the preceding month; used more than 1,500 microg/d of inhaled beclomethasone equivalent; were admission to the intensive care unit (pH<7.30 and/or arterial partial pressure of carbon dioxide (PaCO2) > 70 mm Hg, and/or arterial partial pressure of oxygen (PaO2) < 50 mm Hg despite supplemental oxygen); if a specific cause for the exacerbation, such as pneumonia, pneumothorax, or heart failure, was diagnosed.

Study Design The study was as a randomized, double-blind, parallel design trial. The randomization order was determined using a computer-generated list of random numbers. Eligible patients were randomly allocated to one of the three treatment groups, that is, parenteral corticosteroid (PS), 4 mg nebulized budesonide (NB) or 8 mg NB. The efficacy of the study medications was assessed at hospitalization, 24 h, 48 h and before discharge. Patients were monitored during the hospitalization. Patients were withdrawn from the study if they required intubation and managed in intensive care unit.

Treatments Treatment in the PS group consisted of methylprednisolone 40 mg (intravenous ampoule); treatment in the NB groups consisted of nebulized budesonide suspension (Pulmicort nebuampul® 0.5 mg/ml; Astra-Zeneca Pharmaceutical Production) for 10 days. Budesonide were given as 2 mg twice daily or 4 mg twice daily; methylprednisolone were given once daily intravenously.

Nebulization procedures were performed by jet nebulizer (Porta Neb® Ventstream® 1803; Medic-Aid) with 80% of output of less than 5 micron. Patients received standard treatment with a nebulized ß-agonist (salbutamol 3.01 mg) and anticholinergic (ipratropium bromide 0.5 mg) combination every 6 hours, intravenous aminophylline (0.5 mg/kg/h) and oral or intravenous antibacterial at the discretion of the attending physician. Supplementary oxygen therapy was used to maintain oxygen saturation (SaO2) >90%.

Measurements Patients were assessed every 12 h during the acute phase (from H0 to H48), and at hospital discharge. Arterial blood samples were taken at baseline, 24, 48 h and before discharge for the determination of PaO2, PaCO2, and pH, regardless of whether the patient was on room air or on supplementary oxygen. Spirometry (Sensor Medics, Vmax22) was carried out before and 15 to 20 min after bronchodilator nebulization (ß2-agonist and ipratropium bromide) according to ATS standards. Dyspnea was assessed according to the modified Borg scale. Complete blood cell counts were obtained at entry, and blood glucose, sodium, potassium were measured at H0 and H48.

Endpoints The primary endpoint was to assess treatment efficacy by the change of arterial blood gases from H0 to H24, H48 and before discharge. Secondary endpoints included the changes in FEV1 (forced expiratory volume in 1 second), dyspnea score, duration of hospitalization, and occurrence of adverse events. An adverse event was defined as any medical event reported by the attending physician and events resulting in treatment change, discontinuation study medication or prolonged of hospitalization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Metil prednisolone & Budesonide 4mg
    Interventions:
    • Drug: Budesonide 4 mg
    • Drug: Metil prednisolone
  • Active Comparator: Metil prednisolone & Budesonide 8 mg
    Interventions:
    • Drug: Budesonide 8 mg
    • Drug: Metil prednisolone
  • Active Comparator: Budesonide 4 mg & Budesonide 8 mg
    Interventions:
    • Drug: Budesonide 4 mg
    • Drug: Budesonide 8 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865500
Other Study ID Numbers  ICMJE EUcar
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elif Yilmazel Ucar, Ataturk University
Study Sponsor  ICMJE Ataturk University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ataturk University
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP