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Completed

NCT Number: NCT01651676

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Nord, Amiens, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VQ11 validation

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Likert scales

    Time frame: V2 (3 months after V1)

    To estimate the evolution of dyspnoea and the daily activity by Likert scale.

  5. 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.

  6. Bi-directional visual analogical scale regarding dyspnoea

    Time frame: V2 (3 months after V1)

    To estimate the evolution of dyspnoea since the LABD initiation.

  7. 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.

  8. 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.

  9. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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.

Acronym: EPIC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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