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

U

University of Monastir

Status and phase

Completed
Phase 3

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Treatments

Drug: Bricanyl/Iprovent
Drug: Bricanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT01944033
β2-agonist

Details and patient eligibility

About

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.

Full 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)

Enrollment

250 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

250 participants in 2 patient groups

Group Terbutaline
Active Comparator group
Description:
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
Treatment:
Drug: Bricanyl/Iprovent
Group Terbutaline/IB
Experimental group
Description:
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
Treatment:
Drug: Bricanyl

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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