Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Study Overview
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Brief Summary
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A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

Official Title
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An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit) Established history of COPD as diagnosed by a physician Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit Ability to read, comprehend, and record information in the English language Exclusion Criteria: Currently active asthma (receiving asthma therapy and or having asthma symptoms) Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit Previous lung surgery Other respiratory disorders other than COPD Current alcohol, illegal drug, or solvent abuse Females with a positive urine pregnancy test at the study visit

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No group<br>No group | Drug: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal | The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal | The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. | Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered) | 
| Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios | The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC). | Day 1 of a 1-day study | 
| Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% | The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). | Day 1 of a 1-day study | 
| Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% | The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). | Day 1 of a 1-day study | 
| Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. | Day 1 of a 1-day study | 
| Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% | The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. | Day 1 of 1-day study | 
| Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. | Day 1 of 1-day study | 
| Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% | The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. | Day 1 of 1-day study | 
| Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. | Day 1 of a 1-day study | 
| Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% | The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. | Day 1 of a 1-day study | 
| Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups | The number of participants with the indicated affected medical conditions were counted. | Day 1 of a 1-day study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), Spirometry