A Safety, Tolerability and Efficacy Study in Chronic Obstructive Pulmonary Disease (COPD) Patients With QBM076.
Condition: COPD
Intervention: QBM076; Placebo
Intervention description: Supplied in 25 mg and 75 mg capsules; Matching placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD, inflammation, small airways, LCI, PFTs, lung heterogeneity

Summary:

      This was a 2 Part study. Part 1 was a safety and tolerability study in GOLD I-III COPD
      patients. Part 2 was an efficacy study in GOLD I-III COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part 1: Patients, smokers or ex-smokers with stable chronic bronchitis GOLD class
             I-III chronic obstructive pulmonary disease (COPD); forced expiratory volume in 1
             second ≥40% of predicted and forced expiratory volume in 1 second:forced vital
             capacity ratio ≤0.7 post bronchodilator, respectively; diffusing capacity of the lung
             for carbon monoxide ≥40%; a stable medical regimen for at least 4 weeks prior to
             screening. Current smokers can be enrolled if they currently smoke ≤1ppd for last 3
             months.

               -  Part 2: Patients, smokers or ex-smokers with GOLD spirometry class I-III COPD; a
                  stable medical regimen for at least 4 weeks prior to screening; high sensitivity
                  C reactive protein≥1.5 mg/L; forced expiratory volume in 1 second ≥30% of
                  predicted and forced expiratory volume in 1 second:forced vital capacity ratio
                  ≤0.7 post bronchodilator, respectively; with mean lung clearance index 2.5% ≥8;
                  Ex-smokers with at least 10 pack year smoking history; or current smokers with at
                  least 10 pack year smoking history who smoke ≤ 1ppd on average for last 3
                  months.; evidence of air trapping based on radiologic criteria; women of child
                  bearing potential using effective methods of contraception

        Exclusion Criteria:

          -  Part 1:Gold Class IV COPD, of moderate to significant emphysema, or evidence of
             malignancy; medication considered potential for drug drug interaction; creatinine
             clearance <30ml/min; more than 1 exacerbation requiring antibiotics or oral steroids
             and/or hospitalization within 3 months of screening; women of child bearing potential
             • Part 2: Gold spirometry grade IV COPD; medication considered a potential for drug
             drug interaction; serum creatinine ≥1.9 mg/dL; more than 1 exacerbation requiring
             antibiotics or oral steroids within 2 months and/or hospitalization within 3 months of
             screening; any malignancy; evidence of severe emphysema as determined by HRCT; use of
             oral steroids, theophylline, phosphodiesterase-4 inhibitors or oral antibiotic use
             (eg.macrolides)