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

Acute Exacerbation of Chronic Obstructive Airways Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944033
• Other study ID #: ß2-agonist
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2013
• Last updated: January 24, 2018
• Start date: July 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2018
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Airways Disease
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• 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

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	Monastir
Tunisia	University Hospital of Monastir	Monastir,	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital admission rate and ICU admission rate		within 24 hours after ED admission
Secondary	dyspnea score		24 hours after ED admission
Secondary	endotracheal intubation rate		within 24 hours after ED admission