NCT01958814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 22, 2025

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

October 7, 2013

Last Update Submit

December 15, 2025

Conditions

Chronic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Collection at the bedside spirometric values

    gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start

Secondary Outcomes (3)

  • gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow

    between the median baseline and 15 min after the start of treatment

  • gross change in respiratory rate, heart rate and systolic and diastolic blood pressure

    between baseline and 15 min after the start of treatment

  • gross change in dyspnea

    between baseline and 15 min after the start of treatment

Study Arms (2)

Salbutamol - Placebo

EXPERIMENTAL

salbutamol at M0 and M60 placebo administration

Drug: SalbutamolDrug: Placebo

Placebo - Salbutamol

EXPERIMENTAL

placebo at M0 and M60 salbutamol administration

Drug: SalbutamolDrug: Placebo

Interventions

SalbutamolDRUG

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

Also known as: Treatment
Placebo - SalbutamolSalbutamol - Placebo
PlaceboDRUG

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

Also known as: physiological serum
Placebo - SalbutamolSalbutamol - Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Réanimation Médicale - CHR d'Orléans

Orléans, 45000, France

Location

Service de Réanimation

Poitiers, 86000, France

Location

CHRU de Tours

Tours, 37000, France

Location

Related Publications (1)

  • 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.

    PMID: 30589607RESULT

MeSH Terms

Interventions

AlbuterolTherapeutics

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Pierre-François DEQUIN, MD-PhD

    CHRU de TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

February 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 22, 2025

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)