Acute Exacerbation of Chronic Obstructive Airways DiseasePhase 3NCT01944033
β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
A Phase 3 study testing Bricanyl/Iprovent and Bricanyl in people with Acute Exacerbation of Chronic Obstructive Airways Disease, run by University of Monastir at 2 sites in Tunisia.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Airways Disease
- What is being tested?
- Bricanyl/Iprovent and Bricanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesTunisia
- Study dates
- Jul 2013to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Tunisia2 sites
University Hospital of Monastir
Monastir, Monastir Governorate, 5000
Fattouma Bourguiba University Hospital
Monastir, 5000
About this study
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.
Read the 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)
- Being tested
- Bricanyl/Iprovent, Bricanyl
- Keywords
- β2-agonist, Ipratropium Bromide, Chronic Obstructive Pulmonary Disease Exacerbation, Emergency departement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bricanyl/IproventDrug
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
BricanylDrug
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 group | Role | What they receive |
|---|---|---|
| Group Terbutaline | Active comparator | 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 Receives: Drug: Bricanyl/Iprovent |
| Group Terbutaline/IB | Experimental | 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 Receives: Drug: Bricanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital admission rate and ICU admission rate
Measured: within 24 hours after ED admission
Secondary outcomes (2)
dyspnea score
Measured: 24 hours after ED admission
endotracheal intubation rate
Measured: within 24 hours after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Airways DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- semir nouira, Pr, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944033
- Sponsor's protocol ID
- β2-agonist
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2013
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
- ClinicalTrials.gov ID
- NCT01944033
- Acronym / sponsor ID
- β2-agonist
- Keywords
- β2-agonist, Ipratropium Bromide, Chronic Obstructive Pulmonary Disease Exacerbation, Emergency departement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Terbutaline | Active comparator | Drug: Bricanyl/IproventGroup 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/IB | Experimental | Drug: BricanylGroup 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (6 listed)
- GCS ≤ 14
- hypersensitivity to anticholinergic
- severe acidosis
- immediate need for intubation
- lack of patient cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bricanyl/Iprovent5 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 | Drug | Group Terbutaline |
| Bricanyl5 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 | Drug | Group Terbutaline/IB |
Primary outcome
hospital admission rate and ICU admission rate
Time frame: within 24 hours after ED admission
2 secondary outcomes
dyspnea score
Time frame: 24 hours after ED admission
endotracheal intubation rate
Time frame: within 24 hours after ED admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
semir nouira, Pr principal investigator
University of Monastir
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bricanyl/Iprovent and Bricanyl in people with Acute Exacerbation of Chronic Obstructive Airways Disease, run by University of Monastir at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital admission rate and ICU admission rate (time frame: within 24 hours after ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.