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Terbutaline vs Terbutaline + Ipratropium in COPD Exacerbation
NCT01944033Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Jul 2016
- Countries
- 1
- Sponsor
- Université de Monastir
- Modality
- Small Molecules
- Drugs
- ipratropium bromide
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised trial of ipratropium bromide in chronic obstructive pulmonary disease (COPD) (2 arms), sponsored by Université de Monastir. Primary endpoints: Hospital admission rate at 24 hours and ICU admission rate at 24 hours. Started Jul 2013; status: completed.
02
Design
2 arms- Study design
- Randomized
Group Terbutaline
Terbutaline sulfate (5mg) + saline nebulization
Group Terbutaline/IB
Terbutaline sulfate (5mg) + Ipratropium bromide (0.5mg) + saline nebulization
03
Who it enrols
Adult patients with acute exacerbation of COPD requiring non-invasive ventilation based on blood gas abnormalities (PaCO2 > 45 mmHg, pH < 7.35, SaO2 < 90%). Patients with severe acidosis, immediate need for intubation, or hemodynamic instability are excluded.
04
Endpoints
Primary
Hospital admission rate
ICU admission rate
Secondary
Dyspnea score
Endotracheal intubation rate
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