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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651676
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date August 10, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
VQ11 score [ Time Frame: V1 (at baseline), V2 (3 months after V1) ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01651676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
  • VQ11 and visual analogical scale regarding daily activity [ Time Frame: V1 (at baseline), V2 (3 months after V1) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
Official Title  ICMJE 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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE COPD
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: COPD arm

VQ11 validation:

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

Intervention: Other: VQ11 validation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2012)
250
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651676
Other Study ID Numbers  ICMJE PI2011_843_0006
2011-A01653-38 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles DAYEN, MD University Hospital of Amiens
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP