Please select the arm or intervention descriptions that belong 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: Arm Label: fluticasone propionate/salmeterol; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate/salmeterol 50/250mcg, Drug: tiotropium bromide placebo, Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg | Arm Label: tiotropium bromide; Type: EXPERIMENTAL; Interventions: Drug: fluticasone propionate/salmeterol placebo, Drug: tiotropium bromide 18mcg, Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg | Intervention Type: DRUG; Name: fluticasone propionate/salmeterol 50/250mcg; Assigned to Arm(s): fluticasone propionate/salmeterol | Intervention Type: DRUG; Name: fluticasone propionate/salmeterol placebo; Assigned to Arm(s): tiotropium bromide | Intervention Type: DRUG; Name: tiotropium bromide 18mcg; Assigned to Arm(s): tiotropium bromide | Intervention Type: DRUG; Name: tiotropium bromide placebo; Assigned to Arm(s): fluticasone propionate/salmeterol | Intervention Type: DRUG; Name: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg; Assigned to Arm(s): fluticasone propionate/salmeterol, tiotropium bromide
B: Arm Label: ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Propionate/Salmeterol | Arm Label: SPIRIVA® HANDIHALER® inhaler; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium Bromide | Intervention Type: DRUG; Name: Tiotropium Bromide; Assigned to Arm(s): SPIRIVA® HANDIHALER® inhaler | Intervention Type: DRUG; Name: Fluticasone Propionate/Salmeterol; Assigned to Arm(s): ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler
C: Arm Label: N/A (Survey study); Type: N/A; Interventions: Other: Non-Interventional | Intervention Type: OTHER; Name: Non-Interventional; Assigned to Arm(s): N/A (Survey study)
D: Arm Label: Symbicort+TIO; Type: ACTIVE_COMPARATOR; Interventions: Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) | Arm Label: Spiriva® + Placebo Turbuhaler; Type: ACTIVE_COMPARATOR; Interventions: Drug: Spiriva (tiotropium bromide 18ug) | Intervention Type: DRUG; Name: Symbicort (budesonide/formoterol turbuhaler 320/9ug); Assigned to Arm(s): Symbicort+TIO | Intervention Type: DRUG; Name: Spiriva (tiotropium bromide 18ug); Assigned to Arm(s): Spiriva® + Placebo Turbuhaler

Answer: C