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

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

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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