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

Phase 3

Completed

• Conditions: Acute Exacerbation of Chronic Obstructive Airways Disease
• Interventions: Drug: Bricanyl/Iprovent; Drug: Bricanyl

• Registration Number: NCT01944033
• Lead Sponsor: University of Monastir

Brief Summary

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.

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)

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2016-07
• Study Completion: 2017-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Terbutaline	Bricanyl/Iprovent	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
Group Terbutaline/IB	Bricanyl	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

Primary Outcome Measures

Name	Time	Method
hospital admission rate and ICU admission rate	within 24 hours after ED admission

Secondary Outcome Measures

Name	Time	Method
dyspnea score	24 hours after ED admission
endotracheal intubation rate	within 24 hours after ED admission

Trial Locations

Locations (2)

University Hospital of Monastir; 🇹🇳 Monastir,, Monastir, Tunisia

Fattouma Bourguiba University Hospital; 🇹🇳 Monastir, Tunisia