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

January 24, 2018 updated by: Pr. Semir Nouira, University of Monastir
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Fattouma Bourguiba University Hospital
    • Monastir
      • Monastir,, Monastir, Tunisia, 5000
        • University Hospital of Monastir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

  • Principal Investigator: Semir Nouira, Pr, University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • β2-agonist

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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