An interventional study of VQ11 validation in COPD, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 17 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Screening
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.
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
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
VQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire
Other: VQ11 validation
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.
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).
Time frame: V1 (at baseline), V2 (3 months after V1)
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.
Time frame: 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.
Time frame: 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
Time frame: V1 (at baseline), V2 (3 months after V1)
Likert scales
To estimate the evolution of dyspnoea and the daily activity by Likert scale.
Time frame: 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.
Time frame: 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.
Time frame: V2 (3 months after V1)
Bi-directional visual analogical scale regarding daily activity
To estimate the evolution of daily activity since the LABD initiation.
Time frame: 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.
Time frame: 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).
Time frame: V1 (at baseline), V2 (3 months after V1)
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Centre Hospitalier Universitaire, Amiens