COPDEPICNCT01651676
Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
A study testing VQ11 validation in people with COPD, run by Centre Hospitalier Universitaire, Amiens at 17 sites in France.
Trial summary
The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- VQ11 validation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 17 sitesFrance
- Study dates
- Feb 2013to Dec 2015
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patient with stage II, III ou IV justifying a LABD
- Patient in stable state (without exacerbation in the previous 6 weeks)
- Clinical criteria: dyspnoea stage I ou more (MMRC scale)
- Adult over 18 years old.
- Patients naïve from LABD treatment.
Who cannot join
- Other associated pathology (bronchiectasia...)
- Heart disorder with a prevailing role in the dyspnoea
- Cardiac decompensation in the previous year
- Pregnancy and lactating
- Women in genital activity without efficient contraception method (IUD or estrogen-progestin pill)
- Lack of social insurance
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- Patient non compliant to protocol, at the investigator's appreciation
- Simultaneous participation to other clinical trial.
- adult under judicial protection (tutor or curator).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Clinique de l'Europe
Amiens, 80000
CHU Amiens Nord
Amiens, 80054
CHU Amiens Sud
Amiens, 80054
Centre Hospitalier de Chauny
Chauny, 02300
Centre Hospitalier de Compiègne
Compiègne, 60200
Centre Médical
Compiègne, 60200
CH Creil
Creil, 60109
Centre Médical
Denain, 59220
CH de DOUAI
Douai, 59507
Hopital Jacques MONOD
Le Havre, 76083
Centre Médical
Le Havre, 76600
CHRU de Lille
Lille, 59037
Hopital Maison Blanche
Reims, 51092
CHU de Rouen
Rouen, 76000
Centre hospitalier de St Quentin
Saint-Quentin, 02321
Zac Gouraud
Soissons, 02200
Résidence Saint Michel
Valenciennes, 59300
About this study
Official title: Evaluation of the VQ11 Auto-questionnaire of Quality of Life in Pneumology Investigation, During the Implementation of a Long-acting Bronchodilator Treatment of Patients With COPD.
The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.
The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.
Read the detailed description
Evaluation of the VQ11 auto-questionnaire of quality of life in pneumology investigation, during the implementation of a long-acting bronchodilator treatment of patients with COPD.
Two visits per patient are planned:
V1: After complete information and collection of the written consent, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
V2 (3 months after the treatment setup, at day90 ± 15): the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales and Likert scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
Inclusion period : 6 months; Study participation period / patient : 3 months; Complete study duration : 9 months
- Conditions
- COPD
- Being tested
- VQ11 validation
- Keywords
- VQ11 questionnaire, COPD, LBD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VQ11 validationOther
Two visits per patient are planned: V1 and V2.
For each visit, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, which will be correlated to the other parameters (Likert scale, IPAQ, RFE, SGRQ,...)
LABD treatment consist in β 2 agonists or anticholinergic drug.
| Study group | Role | What they receive |
|---|---|---|
| COPD arm | Experimental | VQ11 validation:
Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire Receives: Other: VQ11 validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VQ11 score
To compare changes of total Score of the VQ11 auto-questionnaire before and after LABD (decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD).
Measured: V1 (at baseline), V2 (3 months after V1)
Secondary outcomes (9)
VQ11 and visual analogical scale regarding daily activity
To estimate the daily activity by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes.
Measured: V1 (at baseline), V2 (3 months after V1)
RFE
Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation.
Measured: V1 (at baseline), V2 (3 months after V1)
VQ11 sub-scores
To estimate the impact of an LABD treatment on patients with COPD before and three months after treatment initiation through the three sub-dimensions of the VQ11 questionnaire
Measured: V1 (at baseline), V2 (3 months after V1)
Likert scales
To estimate the evolution of dyspnoea and the daily activity by Likert scale.
Measured: V2 (3 months after V1)
VQ11 and visual analogical scales regarding dyspnoea
To estimate the dyspnoea by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes.
Measured: V1 (at baseline), V2 (3 months after V1)
Bi-directional visual analogical scale regarding dyspnoea
To estimate the evolution of dyspnoea since the LABD initiation.
Measured: V2 (3 months after V1)
Bi-directional visual analogical scale regarding daily activity
To estimate the evolution of daily activity since the LABD initiation.
Measured: V2 (3 months after V1)
Saint George's Respiratory Questionnaire
To estimate the impact of an LABD treatment on patients with COPD before and three months after treatment initiation using the SGRQ change between the two visits.
Measured: V1 (at baseline), V2 (3 months after V1)
Dyspnoea evolution assessed by mMRC
To estimate the impact of the LABD treatment on dyspnoea of patients with COPD before and three months after treatment initiation through the change of the Modified Medical Research Council dyspnoea scale (mMRC).
Measured: V1 (at baseline), V2 (3 months after V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles DAYEN, MD, Principal investigator, University Hospital of Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651676
- Sponsor's protocol ID
- PI2011_843_0006
- Other IDs
- 2011-A01653-38
- Acronym
- EPIC
- Status last verified
- Nov 2025
- First submitted
- 29 Jun 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
https://doi.org/10.1016/j.rmr.2015.10.647 Évaluation par auto-questionnaire de qualité de vie VQ11 de l'impact d'un traitement bronchodilatateur dans la BPCO en pratique pneumologique Revue des Maladies Respiratoires Volume 33, Supplement, January 2016, Page A34
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the VQ11 Auto-questionnaire of Quality of Life in Pneumology Investigation, During the Implementation of a Long-acting Bronchodilator Treatment of Patients With COPD.
- ClinicalTrials.gov ID
- NCT01651676
- Acronym / sponsor ID
- EPIC / PI2011_843_0006
- Conditions
- COPD
- Keywords
- VQ11 questionnaire, COPD, LBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- 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 purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.
The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.
Detailed description
Evaluation of the VQ11 auto-questionnaire of quality of life in pneumology investigation, during the implementation of a long-acting bronchodilator treatment of patients with COPD.
Two visits per patient are planned:
V1: After complete information and collection of the written consent, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
V2 (3 months after the treatment setup, at day90 ± 15): the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales and Likert scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
Inclusion period : 6 months; Study participation period / patient : 3 months; Complete study duration : 9 months
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD arm | Experimental | Other: VQ11 validationVQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patient with stage II, III ou IV justifying a LABD
- Patient in stable state (without exacerbation in the previous 6 weeks)
- Clinical criteria: dyspnoea stage I ou more (MMRC scale)
- Adult over 18 years old.
- Patients naïve from LABD treatment.
Key exclusion criteria (9 listed)
- Other associated pathology (bronchiectasia...)
- Heart disorder with a prevailing role in the dyspnoea
- Cardiac decompensation in the previous year
- Pregnancy and lactating
- Women in genital activity without efficient contraception method (IUD or estrogen-progestin pill)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VQ11 validationTwo visits per patient are planned: V1 and V2. For each visit, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, which will be correlated to the other parameters (Likert scale, IPAQ, RFE, SGRQ,...) LABD treatment consist in β 2 agonists or anticholinergic drug. | Other | COPD arm |
Primary outcome
VQ11 score
Time frame: V1 (at baseline), V2 (3 months after V1)
To compare changes of total Score of the VQ11 auto-questionnaire before and after LABD (decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD).
9 secondary outcomes
VQ11 and visual analogical scale regarding daily activity
Time frame: V1 (at baseline), V2 (3 months after V1)
RFE
Time frame: V1 (at baseline), V2 (3 months after V1)
VQ11 sub-scores
Time frame: V1 (at baseline), V2 (3 months after V1)
Likert scales
Time frame: V2 (3 months after V1)
VQ11 and visual analogical scales regarding dyspnoea
Time frame: V1 (at baseline), V2 (3 months after V1)
Bi-directional visual analogical scale regarding dyspnoea
Time frame: V2 (3 months after V1)
Bi-directional visual analogical scale regarding daily activity
Time frame: V2 (3 months after V1)
Saint George's Respiratory Questionnaire
Time frame: V1 (at baseline), V2 (3 months after V1)
Dyspnoea evolution assessed by mMRC
Time frame: V1 (at baseline), V2 (3 months after V1)
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 19 Nov 2025.
- Results publicationhttps://doi.org/10.1016/j.rmr.2015.10.647 Évaluation par auto-questionnaire de qualité de vie VQ11 de l'impact d'un traitement bronchodilatateur dans la BPCO en pratique pneumologique Revue des Maladies Respiratoires Volume 33, Supplement, January 2016, Page A34
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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.
Charles DAYEN, MD principal investigator
University Hospital of Amiens
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VQ11 validation in people with COPD, run by Centre Hospitalier Universitaire, Amiens at 17 sites in France.
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 5 inclusion and 9 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in 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?
VQ11 score (time frame: V1 (at baseline), V2 (3 months after V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651676, which also lists 1 linked publication.
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 19 Nov 2025.