COPD
Conditions
Keywords
VQ11 questionnaire, COPD, LBD
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
Interventions
OTHERVQ11 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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VQ11 score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFE | V1 (at baseline), V2 (3 months after V1) | Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation. |
| VQ11 sub-scores | V1 (at baseline), V2 (3 months after V1) | 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 |
| Likert scales | V2 (3 months after V1) | To estimate the evolution of dyspnoea and the daily activity by Likert scale. |
| VQ11 and visual analogical scales regarding dyspnoea | V1 (at baseline), V2 (3 months after V1) | To estimate the dyspnoea by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes. |
| VQ11 and visual analogical scale regarding daily activity | V1 (at baseline), V2 (3 months after V1) | To estimate the daily activity by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes. |
| Bi-directional visual analogical scale regarding daily activity | V2 (3 months after V1) | To estimate the evolution of daily activity since the LABD initiation. |
| Saint George's Respiratory Questionnaire | V1 (at baseline), V2 (3 months after V1) | 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. |
| Dyspnoea evolution assessed by mMRC | V1 (at baseline), V2 (3 months after V1) | 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). |
| Bi-directional visual analogical scale regarding dyspnoea | V2 (3 months after V1) | To estimate the evolution of dyspnoea since the LABD initiation. |
Countries
France
Outcome results
None listed