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

NCT ID: NCT01651676

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-12-31

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

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

COPD arm

VQ11 validation:

Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire

Group Type: EXPERIMENTAL

VQ11 validation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles DAYEN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Amiens

Locations

Clinique de l'Europe

Amiens, , France

CHU Amiens Nord

Amiens, , France

CHU Amiens Sud

Amiens, , France

Centre Hospitalier de Chauny

Chauny, , France

Centre Hospitalier de Compiègne

Compiègne, , France

Centre Médical

Compiègne, , France

CH Creil

Creil, , France

Centre Médical

Denain, , France

CH de DOUAI

Douai, , France

Hopital Jacques MONOD

Le Havre, , France

Centre Médical

Le Havre, , France

CHRU de Lille

Lille, , France

Hopital Maison Blanche

Reims, , France

CHU de Rouen

Rouen, , France

Centre hospitalier de St Quentin

Saint-Quentin, , France

Zac Gouraud

Soissons, , France

Résidence Saint Michel

Valenciennes, , France

Countries

France

References

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

Reference Type: RESULT

Other Identifiers

2011-A01653-38

Identifier Type: OTHER

Identifier Source: secondary_id

PI2011_843_0006

Identifier Type: -

Identifier Source: org_study_id