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

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

COPD

Treatments

Other: VQ11 validation

Study type

Interventional

Funder types

Other

Identifiers

NCT01651676

2011-A01653-38 (Other Identifier)

PI2011_843_0006

Details and patient eligibility

About

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.

Full 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

Enrollment

57 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).