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.
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting|
- The primary outcome for this study will be the proportion of subjects at risk for airway obstruction as measured by the LFQ (LFQ total score ≤ 18) and confirmed by spirometry. [ Time Frame: 4-Month ] [ Designated as safety issue: No ]
- Screening accuracy (sensitivity and specificity) of the LFQ utilizing spirometrically-defined airway obstruction (i.e., a post-bronchodilator FEV1/FVC ≤ 0.7). Proportion of patients with chronic airway obstruction as measured by the LFQ, stratified... [ Time Frame: 4-Month ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
|N/A (Survey study)||
Non-Investigational Product (Survey Study)
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|