A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Arformoterol tartrate inhalation solution; Tiotropium
Intervention description: Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor; Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
Intervention MeSH terms: Tiotropium Bromide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease; COPD; Emphysema; Chronic bronchitis

Summary:

      This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD
      subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet
      the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate
      inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg
      once daily (QD), each given for 90 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects ≥ 55 years-old are eligible for study participation if they
             have a physician-assessed diagnosis of COPD, have been discharged from the hospital
             due to a COPD exacerbation, and at least 1 of the following:

               1. Subject has had 1 or more exacerbations (excluding current exacerbation) within
                  the previous year (exacerbation defined as: an event in the natural course of the
                  disease characterized by a change in the patient's baseline dyspnea, cough and
                  /or sputum beyond day to day variability sufficient to warrant a change in
                  management of COPD (eg, treated with antibiotics and/or systemic corticosteroids
                  or requiring an emergency room visit or an overnight stay at a hospital), OR

               2. Subject has had oxygen therapy use within 3 months prior to study entry.

          2. Subject is a current or ex-smoker with at least 10 pack year smoking history (eg, at
             least 1 pack/day for 10 years, or equivalent).

          3. Subject is willing and able to attend study visits/telephone contacts and adhere to
             all study assessments/procedures.

          4. Subject is willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Subject has current evidence or recent history of any clinically significant and
             unstable disease (other than COPD) or abnormality in the opinion of the Investigator
             that would put the subject at risk or which would compromise the quality of the study
             data; including but not limited to cardiovascular disease, myocardial infarction,
             cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled
             diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease
             or electrolyte abnormalities.

          2. Subject has a primary diagnosis of asthma.

          3. Subject has a history of tuberculosis, bronchiectasis or other non-specific pulmonary
             disease.

          4. Subject has a history of urinary retention or bladder neck obstruction type symptoms.

          5. Subject has a history of narrow angle glaucoma.

          6. Subject has a recent history (previous 12 months) of excessive use or abuse of alcohol
             or narcotic/illegal drugs, as assessed by the Investigator.

          7. Subject has a history of hypersensitivity or intolerance to aerosol medications,
             beta-2 agonists, or anticholinergics.

          8. Subject is participating in another investigational drug study where drug was received
             within 30 days prior to Screening, or current participation in another investigational
             drug trial.

          9. Subject is a staff member of the clinical site or a relative of a clinical site staff
             member.