ADOAIR250 Anti-inflammatory Effects in Japanese Subjects With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: ADOAIR250; Placebo
Intervention description: 250 mcg inhalation, twice daily, from week0 -12.; Placebo inhalation, twice daily, from week0 -12.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Japan; COPD; CAT; placebo; serum; Adoair250; anti-inflammatory; sputum

Summary:

      The study will be conducted in a respiratory specialist institute in Japan, with standardized
      techniques and data assurance checks to optimize data quality. The licensed dosage and
      administration of Adoair in Japan will be applied in this study. Each subject will receive
      treatment options in a randomized blinded fashion. Subjects will be randomized following a
      4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for
      12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female
             patients may be enrolled only if they are not of child-bearing potential, or are of
             child-bearing potential who agree to properly use protocol-specified contraceptive
             measures. )

          2. Have a diagnosis of COPD (defined as per the COPD guideline)

          3. Have a FEV1/FVC ratio < 0.70 at 15-60 minutes following use of SALTANOL® INHALER

          4. Have a FEV1 of >= 40% to < 80% of the predicted normal value at 15-60 minutes
             following use of SALTANOL® INHALER

          5. Current or ex-smokers with a smoking history of at least 10 pack-years

          6. Able to use the DISKUS inhaler and the short-acting inhaled anticholinergic drug

          7. Capable of providing written voluntary consent to participate in the study

        Exclusion Criteria:

          1. Diagnosed by the investigator (or subinvestigator) as having bronchial asthma

          2. Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis,
             tuberculosis [including old tuberculosis], pulmonary fibrosis)

          3. Have a chest X-ray (or CT scan) indicating a diagnosis other than COPD that might
             interfere with assessments in the study (This must be assessed using last imaging
             study performed within 6 months prior to Visit 1; or, a chest X-ray must be obtained
             at Visit 1.)

          4. Have chronic respiratory failure

          5. Have undergone lung volume reduction and/or lung transplant

          6. Have had a COPD exacerbation or respiratory infection requiring systemic
             corticosteroid or microbial therapy or hospitalisation, within 6 weeks prior to Visit
             1

          7. Have used inhaled corticosteroids and systemic corticosteroids within 4 weeks prior to
             Visit 1

          8. Have used long-acting β2 agonists (inhaled or patch) within 2 weeks prior to Visit 1

          9. Are unable to stop their short-acting β2 agonist therapy at Visit 1 (During the study
             participation, oxitropium bromide (TERSIGAN) will be used as relief medication.)

         10. Receiving long-term oxygen therapy with oxygen use for more than 12 hours per day

         11. Have a concurrent serious or uncontrolled disease that might interfere with
             assessments in the study (including psychiatric disease, unstable liver disease, and
             heart disease)

         12. Have a QTc > 450 msec (or > 480 msec in patients with bundle branch block) at Visit 1
             (based on average QTc from three consecutive cardiac cycles on ECG)

         13. Have participated in another study and received any other study drug within 4 weeks
             prior to Visit 1

         14. Diagnosed by the investigator (or subinvestigator) as having drug or alcohol
             dependence

         15. Have known or suspected hypersensitivity to bronchodilators, inhaled corticosteroid,
             or lactose

         16. Have known α1 antitrypsin deficiency

         17. Previously enrolled in this study

         18. Judged by the investigator (or subinvestigator) to be inappropriate to participate in
             this study