Back to resultsβ2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Primary Purpose
Acute Exacerbation of Chronic Obstructive Airways Disease
Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Bricanyl/Iprovent
Bricanyl
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Airways Disease focused on measuring β2-agonist, Ipratropium Bromide, Chronic Obstructive Pulmonary Disease Exacerbation, Emergency departement
Eligibility Criteria
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
Sites / Locations
- University Hospital of Monastir
- Fattouma Bourguiba University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group Terbutaline
Group Terbutaline/IB
Arm 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
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
Outcomes
Primary Outcome Measures
hospital admission rate and ICU admission rate
Secondary Outcome Measures
dyspnea score
endotracheal intubation rate
Full Information
NCT ID
NCT01944033
First Posted
September 9, 2013
Last Updated
January 24, 2018
Sponsor
University of Monastir
1. Study Identification
Unique Protocol Identification Number
NCT01944033
Brief Title
β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Official Title
β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Airways Disease
Keywords
β2-agonist, Ipratropium Bromide, Chronic Obstructive Pulmonary Disease Exacerbation, Emergency departement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Terbutaline
Arm Type
Active Comparator
Arm 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
Arm Title
Group Terbutaline/IB
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Bricanyl/Iprovent
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bricanyl
Intervention Description
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
Primary Outcome Measure Information:
Title
hospital admission rate and ICU admission rate
Time Frame
within 24 hours after ED admission
Secondary Outcome Measure Information:
Title
dyspnea score
Time Frame
24 hours after ED admission
Title
endotracheal intubation rate
Time Frame
within 24 hours after ED admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
semir nouira, Pr
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Monastir
City
Monastir,
State/Province
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
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