Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease (EPIC)
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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. |
- 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).
- 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 |
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| 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 |
| France | |
| 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 | |
| CHU Amiens Sud | Active, not recruiting |
| Amiens, France, 80054 | |
| Centre Hospitalier de Chauny | Active, not recruiting |
| Chauny, France, 02300 | |
| Centre Hospitalier de Compiègne | Active, not recruiting |
| Compiegne, France, 60200 | |
| Centre Médical | Not yet recruiting |
| Compiegne, France, 60200 | |
| Contact: Alain LEPILLIEZ, MD | |
| Principal Investigator: Alain LEPILLIEZ, MD | |
| 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 | |
| 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 Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013