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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01013948
First received: November 12, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Other: Non-Interventional

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1574
Study Start Date: February 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
N/A (Survey study) Other: Non-Interventional
Non-Investigational Product (Survey Study)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013948

  Show 40 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01013948     History of Changes
Other Study ID Numbers: 111116
Study First Received: November 12, 2009
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Spirometry
Bronchitis
COPD
Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:
Airway Obstruction
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Smoking
Respiratory Insufficiency
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Habits

ClinicalTrials.gov processed this record on July 22, 2014