Clinical trial NCT01958814: Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.
Official title: Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Respiratory Failure
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Randomization will focus on the treatment administered (placebo or salbutamol ).

After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow
timeFrame: between the median baseline and 15 min after the start of treatment
measure: gross change in respiratory rate, heart rate and systolic and diastolic blood pressure
timeFrame: between baseline and 15 min after the start of treatment
measure: gross change in dyspnea
timeFrame: between baseline and 15 min after the start of treatment
Other outcomes:
Locations:
city: Orléans
country: France
facility: Service de Réanimation Médicale - CHR d'Orléans
city: Poitiers
country: France
facility: Service de Réanimation
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: CHRU de TOURS
name: Pierre-François DEQUIN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.