Prevalence of Chronic Airway Obstruction in Subjects With a History of Cigarette Smoking in a Primary Care Setting
Prevalence of Chronic Airway Obstruction in Subjects With a History of Cigarette Smoking in a Primary Care Setting
This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction
 using the LFQ as a screening tool in primary care patients with a history of cigarette
 smoking and to provide descriptive data of this patient population. The study design is
 multicenter, cross-sectional, and involves a single visit. This study is not intended to
 evaluate the efficacy or safety of any investigational products. Following completion of
 written informed consent, eligible study subjects will complete a single study visit
 encompassing all required study assessments. Study subjects will not receive blinded study
 medication for evaluations of efficacy and safety.

 All eligible patients will complete a self-administered Web survey that will include the LFQ.
 To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for
 obstruction), as well as 5% of patients who score > 18, will be candidates for spirometric
 assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol
 will be self-administered for determination of post-bronchodilator forced expiratory volume
 in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1
 percentage of predicted normal. The study will end when 800 patients have been assessed
 spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved
 first).

 Prior to implementation of the full study, a pilot study will be conducted at two of the
 chosen study sites to pretest the proposed study procedures.
The incidence of COPD is increasing throughout the world, with the vast majority of patients
 with the disease remaining undiagnosed (Coultas et al., 2001) and underreported (Frank et
 al., 2006; Global Initiative for Chronic Obstructive Lung Disease [GOLD], 2003; Peña et al.,
 2000; Takahashi et al., 2003; Van Weel et al., 2002). This is highlighted in a recent study
 that found 63% of patients with a smoking history and spirometry-confirmed COPD had no
 mention of COPD in their medical records (Frank et al., 2006). These findings are indicative
 of a low awareness of the condition among patients with COPD (Stratelis et al., 2004).

 The use of patient-completed questionnaires to assess smoking history and status, respiratory
 symptoms, and socioeconomic status is a reliable and valid method of screening for COPD
 diagnosis and severity (Bednarek et al., 2008). The range of conditions described as COPD has
 led to confusion about disease terminology and difficulty with diagnosis and communication,
 particularly in primary care (Fukuhara et al., 2005; Kesten and Chapman, 1993). Considering
 that approximately 80% of patients diagnosed with COPD are current and previous cigarette
 smokers, mass screening of these populations using office-based spirometry becomes an
 attractive option (Furguson et al., 2000). A questionnaire designed to capture patient
 answers specific to their disease condition could provide invaluable information, which, if
 it correlates adequately with spirometry, could markedly improve diagnosis and provide
 avenues for appropriate treatment decisions. There are data supporting the argument that the
 prevalence of physician-diagnosed COPD is much lower than the prevalence suggested by results
 of population-based spirometric surveys (Chapman, 2004; Fukuchi et al., 2004; Peña et al.,
 2000; Soriano et al., 2000). Evidently, the development of a practical and reliable tool
 could help bridge the gaps in diagnosis and disease awareness. Moreover, prevalence studies
 underscore the need to improve awareness of COPD among cigarette-smoking populations and to
 provide information that could potentially lead patients to seek treatment. Hence, there is a
 need to develop a screening questionnaire able to identify patients at risk of airflow
 obstruction, for further evaluation. The LFQ, developed for this purpose, consists of a
 series of questions pertaining to COPD risk factors and symptoms.

 Specifically, this study will aim to identify patients at risk of airflow obstruction as
 identified by the LFQ, the results of which will be followed for confirmation through
 subsequent spirometry in a subset of subjects. The LFQ will be evaluated against the
 spirometry results comparatively. A minimum age limit of 30 years is selected for subject
 participation in this study for further validation of the LFQ and to ascertain the enrollment
 of an adequately representative subset of subjects who may be bronchitic or asymptomatic for
 COPD, for comparison purposes with subjects with COPD. The study of this subject population
 may increase the sensitivity of COPD diagnosis and potentially provide information that could
 improve disease awareness and, as a consequence, possibly lead to optimization of disease
 management in primary care.

 This is a cross-sectional study to determine the prevalence of symptomatic airway obstruction
 using the LFQ as a screening tool in primary care patients with a history of cigarette
 smoking and to provide descriptive data of this patient population. The study design is
 multicenter, cross-sectional, and involves a single visit. This study is not intended to
 evaluate the efficacy or safety of any investigational products. Following completion of
 written informed consent, eligible study subjects will complete a single study visit
 encompassing all required study assessments. Study subjects will not receive blinded study
 medication for evaluations of efficacy and safety.

 All eligible patients will complete a self-administered Web survey that will include the LFQ.
 To meet both the primary and secondary aims, all patients with LFQ ≤ 18 (current cut-off for
 obstruction), as well as 5% of patients who score > 18, will be candidates for spirometric
 assessment. Only this subset of patients will undergo pulmonary function tests. Albuterol
 will be self-administered for determination of post-bronchodilator forced expiratory volume
 in one-second (FEV1)/forced vital capacity (FVC) ratio and post-bronchodilator FEV1
 percentage of predicted normal. The study will end when 800 patients have been assessed
 spirometrically or 3,000 patients have completed the LFQ (whichever criterion is achieved
 first).

 Prior to implementation of the full study, a pilot study will be conducted at two of the
 chosen study sites to pretest the proposed study procedures.
Inclusion Criteria:

 -  Patients aged 30 years or older

 -  Current or previous cigarette smoker with a history of cigarette smoking of ≥ 10
 pack-years: number of pack years = (number of cigarettes per day/20) × number of years
 smoked) (e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10
 cigarettes per day for 20 years). Previous smokers are defined as those who stopped
 smoking at least 3 months prior to the study visit.

 -  Willing and able to provide written informed consent prior to study participation (on
 day of study visit).

 -  Able to read, write, and comprehend information in English.

 Exclusion Criteria:

 -  Prior to enrollment, prospective subjects will be screened. A subject will be excluded
 from the study if he/she meets any of the following criteria:

 -  Regular use (i.e., prescribed for use on a daily basis) of the following respiratory
 medications within the 4 weeks prior to the study visit:

 -  Ipratropium (Atrovent, ipratropium bromide)

 -  Ipratropium/albuterol combinations (e.g., Combivent)

 -  Tiotropium (Spiriva, tiotropium bromide)

 -  Salmeterol (SEREVENT™)

 -  Formoterol (Foradil)

 -  Inhaled corticosteroids (e.g., FLOVENT™, BECLOVENT™, Azmacort Aerobid, Pulmicort,
 QVAR, Vanceril)

 -  Inhaled corticosteroid/long-acting beta-agonist combinations (e.g., ADVAIR
 DISKUS™ , Symbicort)

 -  Theophyllines (e.g., Theo-dur, Slo-Bid, Uniphyl)

 -  Oral beta-agonists (e.g.,Volmax)

 -  Previous lung surgery, including lung transplant, lung resection, lung volume
 reduction surgery (e.g., lobectomy, pneumonectomy).

 -  A known diagnosis of a significant lung condition including lung cancer, cystic
 fibrosis, pulmonary fibrosis, active tuberculosis, or sarcoidosis. A previous
 diagnosis of an obstructive lung disease is not exclusionary-asthma, chronic
 bronchitis, emphysema, alpha1-antitrypsin (A1AT) deficiency, etc.

 -  Current participation in a respiratory-related research study and receiving
 experimental medications.

 -  Limited ability to provide a valid informed consent due to serious uncontrolled
 psychiatric disease, intellectual or cognitive deficiency, poor motivation, current
 substance abuse (including drugs and alcohol), or other relevant condition that, in
 the opinion of the site principal investigator, will interfere with the subject's
 participation in the study.

 -  Pregnant females.

 -  Any medical or physical condition such as acute respiratory infection that would
 interfere with the adequate performance of spirometry.

 -  Participating investigator, sub-investigator, study coordinator, employee of the
 participating investigator, or family member of the aforementioned site staffs.