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NCT Number: NCT01944033

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

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.

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Key information

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Monastir, Monastir, Monastir Governorate, Tunisia

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bricanyl/Iprovent

Drug

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

Bricanyl

Drug

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

Primary outcomes

  1. hospital admission rate and ICU admission rate

    Time frame: within 24 hours after ED admission

Secondary outcomes

  1. dyspnea score

    Time frame: 24 hours after ED admission

  2. endotracheal intubation rate

    Time frame: within 24 hours after ED admission

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 17, 2013
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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