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

Completed

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT01013948

Run by

GlaxoSmithKline

People needed

1574

Starts

2009-02-01

Expected to finish

2009-05-01

Last updated by the study team

2012-10-18

Who can join

Age: 30 and older, up to 87. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Adamsville, Alabama, United States
• GSK Investigational Site — Foothill Ranch, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Los Gatos, California, United States
• GSK Investigational Site — Rolling Hills Estate, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Solana Beach, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Torrance/California, California, United States
• GSK Investigational Site — Tulare, California, United States
• GSK Investigational Site — Altmonte Springs, Florida, United States
• GSK Investigational Site — Belle Glade, Florida, United States
• GSK Investigational Site — Green Cove Springs, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Oviedo, Florida, United States
• GSK Investigational Site — Sebastian, Florida, United States
• GSK Investigational Site — Conyers, Georgia, United States
• GSK Investigational Site — Snellville, Georgia, United States
• GSK Investigational Site — Northbrook, Illinois, United States
• GSK Investigational Site — Vernon Hills, Illinois, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Williamsburg, Kentucky, United States
• GSK Investigational Site — Reisterstown, Maryland, United States
• GSK Investigational Site — West Plains, Missouri, United States
• GSK Investigational Site — Brick, New Jersey, United States

Full record on ClinicalTrials.gov

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