Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting
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.


Options:
A: Inclusion Criteria:

* Written informed consent.
* Male or female patients 40 years of age or older.
* Smoking history of at least 10 pack years.
* Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1\<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

* Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
* Myocardial infarction in past 6 months.
* Unstable or life threatening arrhythmia in past year.
* Hospitalization for NYHA heart failure class III or IV in past year.
* Active tuberculosis.
* Asthma.
* Pulmonary resection.
* Malignancy treated with radiation or chemotherapy in past 5 years.
* Respiratory infection in 4 weeks prior to screening.
* Known hypersensitivity to anticholinergic drugs or components.
* Known moderate to severe renal impairment.
* Known narrow angle glaucoma.
* Significant symptomatic BPH or bladder neck obstruction.
* Need for oxygen therapy \>12 hr/day.
* Use of oral corticosteroids at unstable doses or \>10 mg/day.
B: Inclusion Criteria:

* Has an established clinical history of COPD as defined as per the GOLD definition.
* Post-bronchodilator FEV1 of \>30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%.
* Current or ex-smoker with a smoking history of \> 10 pack-years.

Exclusion Criteria:

* Has unstable COPD (Chronic Obstructive Pulmonary Disease).
* Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as \> 12 hours oxygen use per day).
C: Inclusion Criteria:

* Current or ex-smokers
* aged over 50years
* FEV1/FVC ratio less than 0.7
* FEV1 less than 60% predicted

Exclusion Criteria:

* Diagnosis of asthma, ABPA or bronchiectasis
* Recent RTI or steroid use
* Inability to perform study procedures or to give informed consent
* Known sensitivity to trial medications
D: 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.

Answer: D