Chronic Obstructive Pulmonary DiseaseMorphoCOPD1bNCT03102970
Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2015to 5 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease
Who may be able to join
- ≥ 40 years
- smoking at least ≥ 10 pack years
- previous FEV / FVC <0.70 post bronchodilator
- admitted for exacerbations (GOLD definition)
Who cannot join
- A dementia or non-communicating patient
- Patient with chronic pain of neoplastic origin or severe trauma (fracture , dislocation or severe pain) within 15 days before the date of inclusion
- Patient with no social security insurance , with restricted liberty or under legal protection
- Pregnant woman parturient or nursing
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Emergency department of Hôpital du Sacré Coeur de Montréal
Montreal
About this study
Official title: Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
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).
Read the detailed description
Chronic pain is common in patients with Chronic Obstructive pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbation. Fifty (50) patients in acute exacerbation of COPD will be included in the emergency department of CHU Grenoble Alpes and Hôpital du Sacré Coeur de Montréal. The intensity and characteristics of pain will be evaluated from the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Brief Pain Inventory (BPI). Assessment of respiratory status, anxiety and depression, and clinical and biological data, defining the severity of exacerbation, will also be collected. A 30-day follow-up visit, after a return to the stable state of COPD, allowed the realization of Respiratory Functional Exploration and the same questionnaires.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pain, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startDec 2015
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime MAIGNAN, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102970
- Sponsor's protocol ID
- 38RC15.324
- Other IDs
- DR-2016-269
- Acronym
- MorphoCOPD1b
- Status last verified
- Feb 2018
- First submitted
- 31 Mar 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morpho-COPD1b : Pain Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations.
- ClinicalTrials.gov ID
- NCT03102970
- Acronym / sponsor ID
- MorphoCOPD1b / 38RC15.324
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pain, Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Chronic pain is common in patients with Chronic Obstructive pulmonary Disease (COPD). The pain intensity may increase during acute episodes of exacerbation. Fifty (50) patients in acute exacerbation of COPD will be included in the emergency department of CHU Grenoble Alpes and Hôpital du Sacré Coeur de Montréal. The intensity and characteristics of pain will be evaluated from the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Brief Pain Inventory (BPI). Assessment of respiratory status, anxiety and depression, and clinical and biological data, defining the severity of exacerbation, will also be collected. A 30-day follow-up visit, after a return to the stable state of COPD, allowed the realization of Respiratory Functional Exploration and the same questionnaires.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to emergency department for acute episodes of exacerbation of chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- ≥ 40 years
- smoking at least ≥ 10 pack years
- previous FEV / FVC <0.70 post bronchodilator
- admitted for exacerbations (GOLD definition)
Key exclusion criteria (4 listed)
- A dementia or non-communicating patient
- Patient with chronic pain of neoplastic origin or severe trauma (fracture , dislocation or severe pain) within 15 days before the date of inclusion
- Patient with no social security insurance , with restricted liberty or under legal protection
- Pregnant woman parturient or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days
Time frame: 30 days after exacerbation
McGill Pain Questionnaire (SF-MPQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime MAIGNAN principal investigator
University Hospital, Grenoble
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the short-form McGill Pain Questionnaire (SF-MPQ) between the exacerbation and the stable phase at 30 days (time frame: 30 days after exacerbation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.