Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Eff… (NCT01958814) | Clinical Trial Compass
CompletedPhase 2
Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.
France43 participantsStarted 2012-02
Plain-language summary
randomized double-blind controlled study in parallel groups
Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.
During this administration, non invasive ventilation for the patient will be continued.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient over 18 years old
* Patient with BPCO, defined:
* by an irreversible obstructive syndrome
* and\\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood)
* Decompensation of this BPCO in the form of acute respiratory failure
* No argument for a dominant acute left cardiac insufficiency
* Consent signed by the patient
* Patient with national health assurance
Exclusion Criteria:
* Contraindications in the not invasive ventilation
* Patient not volunteer for the realization of the spirometry
* Precautions for use of ß2 mimetic (engrave hyperthyroidism)
* Under guardianship patient or protection of justice
* Pregnant patient
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection at the bedside spirometric values
Timeframe: gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start