Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
Condition: COPD
Intervention: QVA149 110/50 micrograms; Salmeterol/fluticasone 50/500 microgrammes
Intervention description: QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI); Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 500.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This study will investigate whether switching symptomatic COPD patients from a fixed-dose
      combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149
      110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on
      symptom burden, breathlessness, and use of rescue medication after this switch.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Male and female ≥ 40 years

          -  Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack
             years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for
             20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at
             visit 1

          -  Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and < 80% of the
             predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1

          -  Treated with salmeterol/fluticasone 50/500 µg b.i.d. for at least 3 months prior to
             visit 1

          -  Documented CAT score of ≥ 10 at Visit 1 and 2

        Exclusion Criteria:

          -  Treatment with any LAMA in the 2 weeks prior to visit 1

          -  Presence of any contraindication, warning, precaution, hypersensitivity in the
             approved prescribing information for salmeterol/fluticasone

          -  Prior or current diagnosis of asthma

          -  More than one COPD exacerbation requiring treatment with antibiotics and/or systemic
             corticosteroids and/or hospitalization in the year prior to Visit 1

          -  Patients who developed a COPD exacerbation of any severity within the 6 weeks before
             the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit
             2) will not be eligible but will be permitted to be re-screened after a minimum of 6
             weeks after the resolution of the COPD exacerbation

          -  Respiratory tract infection within 4 weeks prior to Visit 1

          -  Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks
             after resolution of the infection

          -  Requiring oxygen therapy prescribed for >12 hours per day

          -  Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years