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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013948
• Other study ID #: 111116
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: October 17, 2012
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1574
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 87 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Non-Interventional
Non-Investigational Product (Survey Study)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Adamsville	Alabama
United States	GSK Investigational Site	Altmonte Springs	Florida
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Belle Glade	Florida
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Conyers	Georgia
United States	GSK Investigational Site	Cortland	Ohio
United States	GSK Investigational Site	Elmhurst	New York
United States	GSK Investigational Site	Flower Mound	Texas
United States	GSK Investigational Site	Foothill Ranch	California
United States	GSK Investigational Site	Grand Prairie	Texas
United States	GSK Investigational Site	Green Cove Springs	Florida
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Lansdowne	Pennsylvania
United States	GSK Investigational Site	Los Gatos	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Manhasset	New York
United States	GSK Investigational Site	Northbrook	Illinois
United States	GSK Investigational Site	Oviedo	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Reisterstown	Maryland
United States	GSK Investigational Site	Richardson	Texas
United States	GSK Investigational Site	Rolling Hills Estate	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Sebastian	Florida
United States	GSK Investigational Site	Snellville	Georgia
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	Vernon Hills	Illinois
United States	GSK Investigational Site	West Plains	Missouri
United States	GSK Investigational Site	Williamsburg	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No