NCT03102970

Brief Summary

The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 12% of the adult population. This prevalence is expected to increase over the coming decades due to the aging of the population and the continued exposure to risk factors for the disease. The evolution of COPD is marked by the occurrence of exacerbations of varying severity and patients are frequently admitted to the emergency department for evaluation, treatment and / or hospitalization. Admission in emergency department for COPD exacerbation represents approximately 1% of emergency admission. Chronic pain is common in patients with Chronic Obstructive Pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbations. This study is aimed to compare pain intensity during exacerbation and stable phase of patients with chronic obstructive pulmonary disease (COPD).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
2 countries

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

December 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2018

Completed
Last Updated

June 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

March 31, 2017

Last Update Submit

June 4, 2018

Conditions

Keywords

COPD, Pain, Exacerbation

Outcome Measures

Primary Outcomes (1)

  • Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days

    McGill Pain Questionnaire (SF-MPQ)

    30 days after exacerbation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease

You may qualify if:

  • ≥ 40 years
  • smoking at least ≥ 10 pack years
  • previous FEV / FVC \<0.70 post bronchodilator
  • admitted for exacerbations (GOLD definition)

You may not qualify if:

  • A dementia or non-communicating patient
  • Patient with no social security insurance , with restricted liberty or under legal protection
  • Pregnant woman parturient or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emergency department of Hôpital du Sacré Coeur de Montréal

Montreal, Canada

Location

Emergency Department of university hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePain

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Maxime MAIGNAN

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

December 1, 2015

Primary Completion

April 5, 2018

Study Completion

April 5, 2018

Last Updated

June 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations