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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01651676
First received: June 29, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
COPD
Other: VQ11 validation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • VQ11 score [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • VQ11 and visual analogical scale regarding daily activity [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    To estimate the daily activity by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes.

  • RFE [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation.

  • VQ11 sub-scores [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: V2 (3 months after V1) ] [ Designated as safety issue: No ]
    To estimate the evolution of dyspnoea and the daily activity by Likert scale.

  • VQ11 and visual analogical scales regarding dyspnoea [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    To estimate the dyspnoea 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 dyspnoea [ Time Frame: V2 (3 months after V1) ] [ Designated as safety issue: No ]
    To estimate the evolution of dyspnoea since the LABD initiation.

  • Bi-directional visual analogical scale regarding daily activity [ Time Frame: V2 (3 months after V1) ] [ Designated as safety issue: No ]
    To estimate the evolution of daily activity since the LABD initiation.

  • Saint George's Respiratory Questionnaire [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: V1 (at baseline), V2 (3 months after V1) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD arm

VQ11 validation:

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

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 β 2 agonists or anticholinergic drug.


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651676

Contacts
Contact: Charles DAYEN, MD 03.22.66.80.60 dayen.charles@chu-amiens.fr
Contact: Loic FIN, PhD +333 22 66 80 60 fin.loic@chu-amiens.fr

Locations
France
CHU Amiens Sud Active, not recruiting
Amiens, France, 80054
CHU Amiens Nord Active, not recruiting
Amiens, France, 80054
Clinique de l'Europe Not yet recruiting
Amiens, France, 80000
Contact: Nicolas BENOIT, MD         
Principal Investigator: Nicolas BENOIT, MD         
Sub-Investigator: Olivier CARRE, MD         
Sub-Investigator: Stéphanie BETHEMBOS, MD         
Centre Hospitalier de Chauny Active, not recruiting
Chauny, France, 02300
Centre Médical Not yet recruiting
Compiegne, France, 60200
Contact: Alain LEPILLIEZ, MD         
Principal Investigator: Alain LEPILLIEZ, MD         
Centre Hospitalier de Compiègne Active, not recruiting
Compiegne, France, 60200
CH Creil Not yet recruiting
Creil, France, 60109
Contact: Gérard LAMARQUE, MD         
Principal Investigator: Gerard LAMARQUE, MD         
Centre Médical Not yet recruiting
Denain, France, 59220
Contact: Jean-Pierre GRIGNET, MD         
Principal Investigator: Jean-Pierre GRIGNET, MD         
CH de DOUAI Active, not recruiting
Douai, France, 59507
Centre Médical Active, not recruiting
Le Havre, France, 76600
Hopital Jacques MONOD Not yet recruiting
Le Havre, France, 76083
Contact: Jean QUIEFFIN, MD         
Principal Investigator: Jean Quieffin, MD         
CHRU de Lille Not yet recruiting
Lille, France, 59037
Contact: Thierry PEREZ, MD         
Principal Investigator: Tierry PEREZ, MD         
Hopital Maison Blanche Active, not recruiting
Reims, France, 51092
CHU de Rouen Not yet recruiting
Rouen, France, 76000
Contact: Jean-François MUIR, MD         
Principal Investigator: Jean-François MUIR, MD         
Centre hospitalier de St Quentin Recruiting
Saint Quentin, France, 02321
Contact: Youcef DOUADI, MD         
Principal Investigator: Youcef DOUADI, MD         
Sub-Investigator: Emmanuelle LECUYER, MD         
Zac Gouraud Active, not recruiting
Soissons, France, 02200
Résidence Saint Michel Active, not recruiting
Valenciennes, France, 59300
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Charles DAYEN, MD University Hospital of Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01651676     History of Changes
Other Study ID Numbers: PI2011_843_0006, 2011-A01653-38
Study First Received: June 29, 2012
Last Updated: April 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
VQ11 questionnaire
COPD
LBD

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014