Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide; Fluticasone; Indacaterol; Salmeterol
Intervention description: Budesonide 400 mcg twice a day via Breezhaler® device; Fluticasone 250 mcg twice daily via Accuhaler® device; Indacaterol 150 mcg once daily via Breezhaler® device; Salmeterol 50 mcg twice daily via Diskus® device
Intervention MeSH terms: Fluticasone; Budesonide; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To demonstrate the free combination of budesonide and indacaterol is as efficacious as
      fluticasone and salmeterol in patients with COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years

          -  Patients with a history of at least one exacerbation.

          -  Patients able to read and complete

        Exclusion Criteria:

          -  Use of other investigational drugs within 30 days

          -  Patients with a history of hypersensitivity to any of the study drugs

          -  History or current diagnosis of ECG abnormalities

          -  Patients with diabetes Type I or uncontrolled diabetes Type II including patients with
             a history of blood glucose levels consistently outside the normal range

          -  Patients who have not achieved an acceptable spirometry result at Visit 1

          -  Patients with a body mass index (BMI) of more than 40 kg/m2

          -  Patients with lung cancer or a history of lung cancer

          -  Patients with a history of malignancy of any organ system

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using effective methods of contraception during
             dosing of study treatment

          -  Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night
             shift workers)

          -  Patients that are uncontrolled or unstable on permitted therapy, who in the opinion of
             the investigator, have clinically significant renal, cardiovascular, neurological,
             endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological
             abnormalities which could interfere with the assessment of the efficacy and safety of
             the study treatment

          -  Patients requiring oxygen therapy for chronic hypoxemia

          -  Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis,
             bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension

          -  Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency.

          -  Patients with history of lung surgery

          -  Patients who are participating in the active phase of a supervised pulmonary
             rehabilitation program.

          -  Patients with a history of asthma Other protocol-defined inclusion/exclusion criteria
             may apply