β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation

Overview

The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already established. The purpose of this study is to compare the effectiveness of the β2-agonists alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment of an acute exacerbation of COPD consulting the emergency departement based on the clinical and arterial blood gas.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2016

Detailed Description

It is a prospective study and randomized performed in patients admitted to the emergency departement for acute exacerbation of COPD. The patients were divided in two groups: Group Terbutaline/Ipratropium Bromide; received Terbutaline + Ipratropium bromide in nebulization and Group Terbutaline received Terbutaline alone in nebulization)

Interventions

  • Drug: Bricanyl/Iprovent
    • 5 mg Terbutaline sulfate (2ml) + 0,5 mg Ipratropium bromide (2ml) + 1ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol
  • Drug: Bricanyl
    • 5 mg Terbutaline sulfate (2ml) + 3ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol

Arms, Groups and Cohorts

  • Active Comparator: Group Terbutaline
    • Group Terbutaline received 5 mg Terbutaline sulfate (2ml) and 3ml serum saline in nebulization repeated three times during 1 hour and every 4 hours during the first 24 hour protocol
  • Experimental: Group Terbutaline/IB
    • Group Terbutaline/Ipratropium Bromide received combination of 5 mg Terbutaline (2ml) and 0.5 mg Ipratropium bromide (2ml) and 1ml serum saline in nebulization repeated threeand every 4 hours during the first 24 hour protocol

Clinical Trial Outcome Measures

Primary Measures

  • hospital admission rate and ICU admission rate
    • Time Frame: within 24 hours after ED admission

Secondary Measures

  • dyspnea score
    • Time Frame: 24 hours after ED admission
  • endotracheal intubation rate
    • Time Frame: within 24 hours after ED admission

Participating in This Clinical Trial

Inclusion Criteria

  • have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph
  • Age over 18 years old.
  • COPD Exacerbation: sustained worsening of patient's condition from stable state necessitating change in regular medication within the last two weeks and need for non invasive ventilation with regard to arterialo blood gas abnormalities: PaCO2 > 45 mmHg, PH<7,35 SaO2<90%

Exclusion Criteria

  • GCS ≤ 14
  • hypersensitivity to anticholinergic
  • severe acidosis
  • immediate need for intubation
  • lack of patient cooperation
  • serious hemodynamic unstability or systolic blood pressure < 90 mmHg, heart arrhythmia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Monastir
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pr. Semir Nouira, Semir Nouira – University of Monastir
  • Overall Official(s)
    • semir nouira, Pr, Principal Investigator, University of Monastir

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