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

NCT01013948 | Completed

• 1 other identifier: 111116
• Study Type: observational
• Target: 1,574
• Locations: 1 country
• Sites: 40

Brief 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

Keywords

Spirometry; Bronchitis; COPD; Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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.

  4-Month

Secondary Outcomes (1)

• 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...

  4-Month

Study Arms (1)

N/A (Survey study)

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Investigational Product (Survey Study)

N/A (Survey study)

Eligibility Criteria

• Age: 30 Years - 87 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Current or previous cigarette smokers of at least 30 years of age with a history of cigarette smoking of ≥ 10 pack-years, recruited from primary care centers.

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).
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (40)

GSK Investigational Site

Adamsville, Alabama, 35005, United States

Location

GSK Investigational Site

Foothill Ranch, California, 92610, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Los Gatos, California, 95032, United States

Location

GSK Investigational Site

Rolling Hills Estate, California, 90274, United States

Location

GSK Investigational Site

San Francisco, California, 94102, United States

Location

GSK Investigational Site

Solana Beach, California, 92075, United States

Location

GSK Investigational Site

Torrance, California, 90505, United States

Location

GSK Investigational Site

Torrance/California, California, 90505, United States

Location

GSK Investigational Site

Tulare, California, 93274, United States

Location

GSK Investigational Site

Altmonte Springs, Florida, 32714, United States

Location

GSK Investigational Site

Belle Glade, Florida, 33430, United States

Location

GSK Investigational Site

Green Cove Springs, Florida, 32043, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32277, United States

Location

GSK Investigational Site

Oviedo, Florida, 32765, United States

Location

GSK Investigational Site

Sebastian, Florida, 32958, United States

Location

GSK Investigational Site

Conyers, Georgia, 30094, United States

Location

GSK Investigational Site

Snellville, Georgia, 30039, United States

Location

GSK Investigational Site

Northbrook, Illinois, 60062, United States

Location

GSK Investigational Site

Vernon Hills, Illinois, 60061, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40222, United States

Location

GSK Investigational Site

Williamsburg, Kentucky, 40769, United States

Location

GSK Investigational Site

Reisterstown, Maryland, 21136, United States

Location

GSK Investigational Site

West Plains, Missouri, 65775, United States

Location

GSK Investigational Site

Brick, New Jersey, '08723, United States

Location

GSK Investigational Site

Elmhurst, New York, 11373, United States

Location

GSK Investigational Site

Manhasset, New York, 11030, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44113, United States

Location

GSK Investigational Site

Cortland, Ohio, 44410, United States

Location

GSK Investigational Site

Lansdowne, Pennsylvania, 19050, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29601, United States

Location

GSK Investigational Site

Austin, Texas, 78745, United States

Location

GSK Investigational Site

Flower Mound, Texas, 75028, United States

Location

GSK Investigational Site

Grand Prairie, Texas, 75052, United States

Location

GSK Investigational Site

Houston, Texas, 77089, United States

Location

GSK Investigational Site

Irving, Texas, 75061, United States

Location

GSK Investigational Site

Lake Jackson, Texas, 77566, United States

Location

GSK Investigational Site

Plano, Texas, 75093, United States

Location

GSK Investigational Site

Richardson, Texas, 75080, United States

Location

Related Publications (2)

• Mintz ML, Yawn BP, Mannino DM, Donohue JF, Hanania NA, Grellet CA, Gilsenan AW, McLeod LD, Dalal AA, Raphiou IH, Prillaman BA, Crater GD, Cicale MJ, Mapel DW. Prevalence of airway obstruction assessed by lung function questionnaire. Mayo Clin Proc. 2011 May;86(5):375-81. doi: 10.4065/mcp.2010.0787.

  PMID: 21531880 BACKGROUND

• Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.

  PMID: 22040533 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (40)