Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
EPIC
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.
2 other identifiers
interventional
57
1 country
17
Brief 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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 19, 2025
November 1, 2025
2.8 years
June 29, 2012
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
V1 (at baseline), V2 (3 months after V1)
Secondary Outcomes (9)
VQ11 and visual analogical scale regarding daily activity
V1 (at baseline), V2 (3 months after V1)
RFE
V1 (at baseline), V2 (3 months after V1)
VQ11 sub-scores
V1 (at baseline), V2 (3 months after V1)
Likert scales
V2 (3 months after V1)
VQ11 and visual analogical scales regarding dyspnoea
V1 (at baseline), V2 (3 months after V1)
- +4 more secondary outcomes
Study Arms (1)
COPD arm
EXPERIMENTALVQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Patient non compliant to protocol, at the investigator's appreciation
- Simultaneous participation to other clinical trial.
- adult under judicial protection (tutor or curator).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Clinique de l'Europe
Amiens, 80000, France
CHU Amiens Nord
Amiens, 80054, France
CHU Amiens Sud
Amiens, 80054, France
Centre Hospitalier de Chauny
Chauny, 02300, France
Centre Hospitalier de Compiègne
Compiègne, 60200, France
Centre Médical
Compiègne, 60200, France
CH Creil
Creil, 60109, France
Centre Médical
Denain, 59220, France
CH de DOUAI
Douai, 59507, France
Hopital Jacques MONOD
Le Havre, 76083, France
Centre Médical
Le Havre, 76600, France
CHRU de Lille
Lille, 59037, France
Hopital Maison Blanche
Reims, 51092, France
CHU de Rouen
Rouen, 76000, France
Centre hospitalier de St Quentin
Saint-Quentin, 02321, France
Zac Gouraud
Soissons, 02200, France
Résidence Saint Michel
Valenciennes, 59300, France
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles DAYEN, MD
University Hospital of Amiens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 27, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 19, 2025
Record last verified: 2025-11