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Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath

4 de enero de 2013 actualizado por: GlaxoSmithKline

An Evaluation of the Prevalence of Airway Obstruction Consistent With Chronic Obstructive Pulmonary Disease (COPD) in Subjects With a History of Cigarette Smoking and Symptoms of Chronic Bronchitis in a Primary Care Setting

The study does not involve testing of a drug (no treatment intervention). The study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

1283

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Highlands Ranch, Colorado, Estados Unidos, 80130
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Estados Unidos, 80033
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, Estados Unidos, 33756
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • GSK Investigational Site
      • Largo, Florida, Estados Unidos, 33770
        • GSK Investigational Site
      • Miami, Florida, Estados Unidos, 33156
        • GSK Investigational Site
    • Illinois
      • Gillespie, Illinois, Estados Unidos, 62033
        • GSK Investigational Site
      • Vernon Hills, Illinois, Estados Unidos, 60061
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, Estados Unidos, 46515
        • GSK Investigational Site
      • Evansville, Indiana, Estados Unidos, 47711
        • GSK Investigational Site
    • Kansas
      • Arkansas City, Kansas, Estados Unidos, 67005
        • GSK Investigational Site
      • Wichita, Kansas, Estados Unidos, 67207
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, Estados Unidos, 70584
        • GSK Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55414
        • GSK Investigational Site
      • Rochester, Minnesota, Estados Unidos, 55904
        • GSK Investigational Site
    • Missouri
      • Nixa, Missouri, Estados Unidos, 65714
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Estados Unidos, 59808
        • GSK Investigational Site
    • Nebraska
      • Fremont, Nebraska, Estados Unidos, 68025
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28209
        • GSK Investigational Site
      • Mooresville, North Carolina, Estados Unidos, 28117
        • GSK Investigational Site
      • Raleigh, North Carolina, Estados Unidos, 27609
        • GSK Investigational Site
      • Salisbury, North Carolina, Estados Unidos, 28144
        • GSK Investigational Site
      • Sylva, North Carolina, Estados Unidos, 28779
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, Estados Unidos, 44122
        • GSK Investigational Site
      • Cincinnati, Ohio, Estados Unidos, 45224
        • GSK Investigational Site
      • Columbus, Ohio, Estados Unidos, 43215
        • GSK Investigational Site
      • Dayton, Ohio, Estados Unidos, 45439
        • GSK Investigational Site
      • Dayton, Ohio, Estados Unidos, 45406
        • GSK Investigational Site
      • Kettering, Ohio, Estados Unidos, 45429
        • GSK Investigational Site
    • Oklahoma
      • Yukon, Oklahoma, Estados Unidos, 73099
        • GSK Investigational Site
    • Pennsylvania
      • Clairton, Pennsylvania, Estados Unidos, 15205
        • GSK Investigational Site
      • Harleysville, Pennsylvania, Estados Unidos, 19438
        • GSK Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, Estados Unidos, 02864
        • GSK Investigational Site
    • South Carolina
      • Gaffney, South Carolina, Estados Unidos, 29340
        • GSK Investigational Site
      • Greenville, South Carolina, Estados Unidos, 29615
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, Estados Unidos, 29464
        • GSK Investigational Site
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • GSK Investigational Site
      • Union, South Carolina, Estados Unidos, 29309
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, Estados Unidos, 37620
        • GSK Investigational Site
      • Harleysville, Tennessee, Estados Unidos, 37087
        • GSK Investigational Site
      • Milan, Tennessee, Estados Unidos, 38358
        • GSK Investigational Site
    • Texas
      • Plano, Texas, Estados Unidos, 75093
        • GSK Investigational Site
    • Virginia
      • Newport News, Virginia, Estados Unidos, 23606
        • GSK Investigational Site
    • Washington
      • Gig Harbor, Washington, Estados Unidos, 98335
        • GSK Investigational Site
      • Tacoma, Washington, Estados Unidos, 98405
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Male or female, ≥40 years of age, current or previous cigarette smokers with ≥10 pack-years of smoking history and self reported symptoms of chronic bronchitis where chronic bronchitis.

Descripción

Inclusion Criteria:

- Male or female - ≥40 years of age - Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years - Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years - Completion of written informed consent prior to study participation - Subject must be able to read, comprehend, and record information in English.

Exclusion Criteria:

- Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. - Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc. - Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency. - Any medical or physical condition that would interfere with the adequate performance of spirometry. - Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit. - A spirometrically confirmed diagnosis of COPD. - Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse. - Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study. - Pregnant females. - Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
All participants
This is a cross-sectional, non-interventional study. All enrolled subjects were asked to complete a questionnaire and pulmonary function test to assess the prevalence of airflow obstruction.
Otro: Non-interventional study.
This is a non-interventional (no drug treatment administered), prevalence (observational) study.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
Periodo de tiempo: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC <=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).
Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale
Periodo de tiempo: Day 1 of a 1-day study
The MRC scale is a 6-point scale (scores from 0 to 5; encompassing degrees of dyspnea of none, slight, moderate, moderately severe, severe, and very severe) used to assess (via a participant-completed questionnaire) the amount of routine daily physical activity that precipitates dyspnea. The levels of physical activity range from strenuous exercise, to walking (including up a slight hill, on level ground, and to 100 yards), and to dressing and undressing.
Day 1 of a 1-day study
Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire
Periodo de tiempo: Day 1 of 1-day study
The Modified ATS Respiratory Questionnaire is a participant-completed questionnaire used to assess pulmonary disease symptomatology (such as cough, phlegm).
Day 1 of 1-day study
Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey
Periodo de tiempo: Day 1 of a 1-day study
The 12-item short form health survey (SF-12, version 2) is a participant-completed questionnaire. The SF-12 Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health.
Day 1 of a 1-day study
FEV1 and FVC, Pre-bronchodilator Spirometry Measures
Periodo de tiempo: Day 1 of a 1-day study
Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).
Day 1 of a 1-day study
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures
Periodo de tiempo: Day 1 of a 1-day study
Participants self-administered a bronchodilator (albuterol) in the presence of trained site staff 15 to 30 minutes prior to pulmonary function test. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).
Day 1 of a 1-day study
FEV1 and FVC, Post-bronchodilator Spirometry Measures
Periodo de tiempo: Day 1 of a 1-day visit
Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. FEV1 is the volume of air expelled from the lungs in 1 second, and FVC is the volume of air that can forcibly be blown out after full inspiration).
Day 1 of a 1-day visit
FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures
Periodo de tiempo: Day 1 of a 1-day study
Participants completed the pulmonary function test 15-30 minutes after bronchodilator administration. The FEV1 percent predicted and FEV1/FVC percent predicted are the test results as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).
Day 1 of a 1-day study
Post-bronchodilator Reversibility Measures
Periodo de tiempo: Day 1 of a 1-day study
To assess the reversibility in COPD, a bronchodilator was administered before performing another round of tests for comparison. This is commonly referred to as a reversibility test for the likelihood for a participant to revert to their baseline spirometric values or a post-bronchodilator test (Post BD) and is an important part in diagnosing asthma versus COPD, particularly since reversibility is not observed in the latter case. This differentiates COPD from other diseases.
Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness
Periodo de tiempo: Day 1 of a 1-day study
Day 1 of a 1-day study
Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status
Periodo de tiempo: Day 1 of a 1-day study
Day 1 of a 1-day study
Number of Participants Who Completed the Highest Indicated Education Level or Grade
Periodo de tiempo: Day 1 of 1-day study
Day 1 of 1-day study
Number of Participants With the Indicated Experience With Tobacco Smoking
Periodo de tiempo: Day 1 of 1-day study
Day 1 of 1-day study
Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History
Periodo de tiempo: Day 1 of 1-day study
IBD, inflammatory bowel disease; GERD, gastroesophageal reflux disease.
Day 1 of 1-day study

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2007

Finalización primaria (Actual)

1 de septiembre de 2007

Finalización del estudio (Actual)

1 de septiembre de 2007

Fechas de registro del estudio

Enviado por primera vez

1 de marzo de 2007

Primero enviado que cumplió con los criterios de control de calidad

1 de marzo de 2007

Publicado por primera vez (Estimar)

2 de marzo de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de enero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

4 de enero de 2013

Última verificación

1 de octubre de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ADC109043

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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