A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD
Condition: COPD
Intervention: Placebo; SUN101 3 mcg; SUN-101 6.25 mcg; SUN-101 12.5 mcg; SUN-101 50 mcg; Aclidinium
Intervention description: Placebo; SUN-101 3 mcg bid; SUN-101 6.25 mcg bid; SUN-101 12.5 mcg bid; SUN-101 50 mcg bid; Aclidinium 400 mcg bid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      Study for subjects 40 to 65 years-old with a diagnosis of moderate to severe COPD. Aclidinium
      bromide 400 mcg 2x a day will be given as an active comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients 40 to 65 years-old, inclusive.

          2. A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.

          3. Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least
             1 pack/day for 10 years, or equivalent).

          4. Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70%
             of predicted normal during Screening.

          5. Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤
             0.70 during Screening.

          6. Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1
             ≥ 12% and ≥ 100 mL during Screening.

          7. Ability to perform reproducible spirometry according to the American Thoracic Society
             (ATS) and European Respiratory Society (ERS) guidelines (2005).

          8. Female of child bearing potential (only) must have a negative serum pregnancy test at
             Screening and be neither breastfeeding nor intending to become pregnant during study
             participation. Females of childbearing potential must be instructed to and agree to
             avoid pregnancy during the study. Female subjects of child bearing potential must use
             an adequate method of birth control from Screening until 30 days after receiving study
             drug and use contraception in addition to their partners using a barrier method.
             Acceptable forms of contraception are as follows:

               -  Abstinence

               -  Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel,
                  film, cream or suppository;

               -  Oral contraceptives

               -  Non hormone containing intrauterine methods: intrauterine devices or systems.

          9. Willing and able to remain at the study site for at least 24 hours at Day 7 of each
             Treatment Period.

         10. Willing and able to attend all study visits and adhere to all study
             assessments/procedures.

         11. Willing and able to provide written informed consent

        Exclusion Criteria:

          1. Current evidence or recent history of any clinically significant and unstable disease
             (other than COPD) or abnormality in the opinion of the Investigator that would put the
             subject at risk or which would compromise the quality of the study data; including but
             not limited to cardiovascular disease, myocardial infarction, cardiac failure,
             uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes,
             neurologic or neuromuscular disease, liver disease, gastrointestinal disease or
             electrolyte abnormalities.

          2. Current evidence or history of a clinically significant abnormality of cardiac rhythm
             and/or conduction including Holter monitoring prior to randomization.

          3. Primary diagnosis of asthma.

          4. History of malignancy of any organ system, treated or untreated within the past 5
             years, with the exception of localized basal cell carcinoma of the skin.

          5. Recent history of COPD exacerbation requiring hospitalization or need for increased
             treatments for COPD within 6 weeks prior to Screening.

          6. Use of daily oxygen therapy > 10 hours per day.

          7. Use of systemic steroids within 3 months prior to Screening.

          8. Respiratory tract infection within 6 weeks prior to or during Screening.

          9. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.

         10. History of urinary retention or bladder neck obstruction type symptoms.

         11. History of narrow angle glaucoma.

         12. Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or
             history of long QT syndrome.

         13. Recent history (previous 12 months) of excessive use or abuse of alcohol or
             narcotic/illegal drugs.

         14. History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or
             anticholinergics.

         15. Participation in another investigational drug study where drug was received within 30
             days prior to Screening, or current participation in another investigational drug
             trial.

         16. Subject is a staff member of the clinical site or a relative of a clinical site staff
             member.