Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
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.

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

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.

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: VQ11 validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD arm<br>VQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire | Other: VQ11 validation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | V1 (at baseline), V2 (3 months after V1) | 
| Likert scales | To estimate the evolution of dyspnoea and the daily activity by Likert scale. | 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. | 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. | V2 (3 months after V1) | 
| Bi-directional visual analogical scale regarding daily activity | To estimate the evolution of daily activity since the LABD initiation. | 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. | 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). | V1 (at baseline), V2 (3 months after V1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VQ11 questionnaire, COPD, LBD