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Prevalence of Chronic Airway Obstruction in Subjects With a History of Cigarette Smoking in a Primary Care Setting

NCT01013948 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1574

Last updated 2012-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

OTHER

Non-Interventional

Non-Investigational Product (Survey Study)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
30 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01013948 on ClinicalTrials.gov