Last updated: 11/03/2018 11:24:54

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

GSK study ID
111116
See study documents
Clinicaltrials.gov ID
NCT01013948
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Prevalence of Chronic Airway Onstruction in a Subject Population with a History of Cigarette Smoking in a Primary care Setting
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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.

Timeframe: 4-Month

Secondary outcomes:

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...

Timeframe: 4-Month

Interventions:
  • Other: Non-Interventional
    • Enrollment:
    1574
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    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.
    Mintz ML, Yawn BP, Mannino DM, et al. Prevalence of airway obstruction assessed by lung function questionnaire. [Mayo Clin Proc]. 2011;86(5):375-381.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to May 2009
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 87 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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:
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lansdowne, Pennsylvania, United States, 19050
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Grand Prairie, Texas, United States, 75052
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Adamsville, Alabama, United States, 35005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Torrance, California, United States, 90505
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29601
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 40 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-29-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website