Clinical trial NCT01651676: Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: VQ11 questionnaire
COPD
LBD
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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).

Primary outcomes:
measure: VQ11 score
timeFrame: V1 (at baseline), V2 (3 months after V1)
Secondary outcomes:
measure: VQ11 and visual analogical scale regarding daily activity
timeFrame: V1 (at baseline), V2 (3 months after V1)
measure: RFE
timeFrame: V1 (at baseline), V2 (3 months after V1)
measure: VQ11 sub-scores
timeFrame: V1 (at baseline), V2 (3 months after V1)
measure: Likert scales
timeFrame: V2 (3 months after V1)
measure: VQ11 and visual analogical scales regarding dyspnoea
timeFrame: V1 (at baseline), V2 (3 months after V1)
measure: Bi-directional visual analogical scale regarding dyspnoea
timeFrame: V2 (3 months after V1)
measure: Bi-directional visual analogical scale regarding daily activity
timeFrame: V2 (3 months after V1)
measure: Saint George's Respiratory Questionnaire
timeFrame: V1 (at baseline), V2 (3 months after V1)
measure: Dyspnoea evolution assessed by mMRC
timeFrame: V1 (at baseline), V2 (3 months after V1)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique de l'Europe
city: Amiens
country: France
facility: CHU Amiens Nord
city: Amiens
country: France
facility: CHU Amiens Sud
city: Chauny
country: France
facility: Centre Hospitalier de Chauny
city: Compiegne
country: France
facility: Centre Hospitalier de Compiègne
city: Compiegne
country: France
facility: Centre Médical
city: Creil
country: France
facility: CH Creil
city: Denain
country: France
facility: Centre Médical
city: Douai
country: France
facility: CH de DOUAI
city: Le Havre
country: France
facility: Hopital Jacques MONOD
city: Le Havre
country: France
facility: Centre Médical
city: Lille
country: France
facility: CHRU de Lille
city: Reims
country: France
facility: Hopital Maison Blanche
city: Rouen
country: France
facility: CHU de Rouen
city: Saint Quentin
country: France
facility: Centre hospitalier de St Quentin
city: Soissons
country: France
facility: Zac Gouraud
city: Valenciennes
country: France
facility: Résidence Saint Michel
Study officials:
affiliation: University Hospital of Amiens
name: Charles DAYEN, MD
role: PRINCIPAL_INVESTIGATOR
References: