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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01944033

Enrollment

250

Registered

2013-09-17

Start date

2013-07-31

Completion date

2017-01-31

Last updated

2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Keywords

β2-agonist, Ipratropium Bromide, Chronic Obstructive Pulmonary Disease Exacerbation, Emergency departement

Brief 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.

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)

Interventions

DRUGBricanyl/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

DRUGBricanyl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
hospital admission rate and ICU admission rate	within 24 hours after ED admission

Secondary

Measure	Time frame
dyspnea score	24 hours after ED admission
endotracheal intubation rate	within 24 hours after ED admission

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026