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Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.

NCT ID: NCT01958814

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-07-31

Brief Summary

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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

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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 ) .

Conditions

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Chronic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Salbutamol - Placebo

salbutamol at M0 and M60 placebo administration

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Placebo

Intervention Type DRUG

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Placebo - Salbutamol

placebo at M0 and M60 salbutamol administration

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Placebo

Intervention Type DRUG

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Interventions

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Salbutamol

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Intervention Type DRUG

Placebo

First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)

Intervention Type DRUG

Other Intervention Names

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Treatment physiological serum

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-François DEQUIN, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU de TOURS

Locations

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Service de Réanimation Médicale - CHR d'Orléans

Orléans, , France

Site Status

Service de Réanimation

Poitiers, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30589607 (View on PubMed)

Other Identifiers

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2011-004802-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHAO11-PD / BANNISTER

Identifier Type: -

Identifier Source: org_study_id