Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Stiolto Respimat; ICS (Inhaled Corticosteroid) (Triple therapy); LABA (Long-Acting Beta Agonist) (Triple therapy); LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Intervention description: Duration - 12 months; Duration - 12 months; Duration - 12 months; Duration - 12 months
Intervention MeSH terms: Cholinergic Agents; Muscarinic Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 714.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this pragmatic study is to compare the time to first moderate or
      severe COPD exacerbation in patients, not controlled on their current therapy, randomized to
      Stiolto Respimat versus triple therapy over 12 months of treatment

      The secondary objectives of this study include:

        1. To compare the annual rate of moderate or severe COPD exacerbations for patients on
           Stiolto Respimat with patients on triple therapy.

        2. To compare the time to first severe COPD exacerbation in both treatment arms.

        3. To compare the annual rate of severe COPD exacerbations in both treatment arms.

        4. To compare the proportion of patients with moderate or severe COPD exacerbations in both
           treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD diagnosis as defined by the study physician

          -  Currently on one of the following maintenance therapies:

               -  LAMA monotherapy

               -  LABA monotherapy

               -  ICS/LABA (FDC)

          -  Physician determination that patient is not controlled on current pharmacotherapy

          -  Adult patient 40 years of age or older at time of study enrollment

          -  Willingness and ability to understand and provide documented Informed Consent Form
             (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization
             Form prior to commencement of any study required assessments, either directly or
             through Legally Authorized Representative.

        Exclusion Criteria:

          -  Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)

          -  Contraindication to any study medications (LAMA, LABA or ICS)

          -  Documented diagnosis of current asthma

          -  Pregnant or nursing women

          -  Women of childbearing potential are not restricted in this trial, however it is
             expected that the investigator will assess the risks and benefits of the assigned
             treatment as per the product label(s) and discuss this with any women of childbearing
             potential prior to providing the patient with the prescription for the assigned
             treatment.