NCT01944033

Brief Summary

The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already established. The purpose of this study is to compare the effectiveness of the β2-agonists alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment of an acute exacerbation of COPD consulting the emergency departement based on the clinical and arterial blood gas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

2 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

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

September 9, 2013

Last Update Submit

January 24, 2018

Conditions

Acute Exacerbation of Chronic Obstructive Airways Disease

Keywords

β2-agonistIpratropium BromideChronic Obstructive Pulmonary Disease ExacerbationEmergency departement

Outcome Measures

Primary Outcomes (1)

  • hospital admission rate and ICU admission rate

    within 24 hours after ED admission

Secondary Outcomes (2)

  • dyspnea score

    24 hours after ED admission

  • endotracheal intubation rate

    within 24 hours after ED admission

Study Arms (2)

Group Terbutaline

ACTIVE COMPARATOR

Group Terbutaline received 5 mg Terbutaline sulfate (2ml) and 3ml serum saline in nebulization repeated three times during 1 hour and every 4 hours during the first 24 hour protocol

Drug: Bricanyl/Iprovent

Group Terbutaline/IB

EXPERIMENTAL

Group Terbutaline/Ipratropium Bromide received combination of 5 mg Terbutaline (2ml) and 0.5 mg Ipratropium bromide (2ml) and 1ml serum saline in nebulization repeated threeand every 4 hours during the first 24 hour protocol

Drug: Bricanyl

Interventions

Bricanyl/IproventDRUG

5 mg Terbutaline sulfate (2ml) + 0,5 mg Ipratropium bromide (2ml) + 1ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol

Group Terbutaline
BricanylDRUG

5 mg Terbutaline sulfate (2ml) + 3ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol

Group Terbutaline/IB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph
  • Age over 18 years old.
  • COPD Exacerbation: sustained worsening of patient's condition from stable state necessitating change in regular medication within the last two weeks and need for non invasive ventilation with regard to arterialo blood gas abnormalities: PaCO2 \> 45 mmHg, PH\<7,35 SaO2\<90%

You may not qualify if:

  • GCS ≤ 14
  • hypersensitivity to anticholinergic
  • severe acidosis
  • immediate need for intubation
  • lack of patient cooperation
  • serious hemodynamic unstability or systolic blood pressure \< 90 mmHg, heart arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

MeSH Terms

Interventions

Terbutaline

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • semir nouira, Pr

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Semir Nouira

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 17, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2016

Study Completion

January 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations

TU(2)