β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Monastir
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- hospital admission rate and ICU admission rate
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •hypersensitivity to anticholinergic
- •severe acidosis
- •immediate need for intubation
- •lack of patient cooperation
- •serious hemodynamic unstability or systolic blood pressure < 90 mmHg, heart arrhythmia
Arms & Interventions
Group Terbutaline
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
Intervention: Bricanyl/Iprovent (Drug)
Group Terbutaline/IB
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
Intervention: Bricanyl (Drug)
Outcomes
Primary Outcomes
hospital admission rate and ICU admission rate
Time Frame: within 24 hours after ED admission
Secondary Outcomes
- endotracheal intubation rate(within 24 hours after ED admission)
- dyspnea score(24 hours after ED admission)
Investigators
Pr. Semir Nouira
Semir Nouira
University of Monastir