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

COPD Clinical Trial

— EPIC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651676
• Other study ID #: PI2011_843_0006
• Secondary ID: 2011-A01653-38
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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 ß 2 agonists or anticholinergic drug.

Locations

Country	Name	City	State
France	CHU Amiens Nord	Amiens
France	CHU Amiens Sud	Amiens
France	Clinique de l'Europe	Amiens
France	Centre Hospitalier de Chauny	Chauny
France	Centre Hospitalier de Compiègne	Compiegne
France	Centre Médical	Compiegne
France	CH Creil	Creil
France	Centre Médical	Denain
France	CH de DOUAI	Douai
France	Centre Médical	Le Havre
France	Hopital Jacques MONOD	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Likert scales	To estimate the evolution of dyspnoea and the daily activity by Likert scale.	V2 (3 months after V1)
Secondary	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)
Secondary	Bi-directional visual analogical scale regarding dyspnoea	To estimate the evolution of dyspnoea since the LABD initiation.	V2 (3 months after V1)
Secondary	Bi-directional visual analogical scale regarding daily activity	To estimate the evolution of daily activity since the LABD initiation.	V2 (3 months after V1)
Secondary	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)
Secondary	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)