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

Phase 3CompletedNCT01944033

University of Monastir250 enrolled

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Interventions

Bricanyl/IproventDRUG

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

BricanylDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital of Monastir

Monastir, Monastir Governorate, Tunisia

Fattouma Bourguiba University Hospital

Monastir, Tunisia

Outcomes

Primary Outcomes

hospital admission rate and ICU admission rate

Time frame: within 24 hours after ED admission

Secondary Outcomes

dyspnea score

Time frame: 24 hours after ED admission

endotracheal intubation rate

Time frame: within 24 hours after ED admission

Data from ClinicalTrials.gov

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