7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Long acting muscarinic antagonist; Chronic Bronchitis; Emphysema; Chronic Obstructive Pulmonary Disease; COPD

Summary:

      This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects
      with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at
             randomization).

          2. Subject:

               -  Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) <0.7
                  at screening; and

               -  Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of
                  the predicted normal value.

          3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of
             receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.

          4. Females of non-childbearing potential. All male subjects must agree to use a highly
             effective method of birth control with partners of childbearing potential during the
             study and for 1 month after completion of study dosing.

          5. Subject (or care giver) is able to properly prepare and administer study medication.

          6. Subject is willing and able to give written informed consent to participate.

        Exclusion Criteria:

          1. Subject has had a COPD exacerbation or lung infection within 6 weeks before
             randomization.

          2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral
             corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic
             antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response
             test.

          3. Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of
             fluticasone propionate equivalent or ≥10 mg prednisone).

          4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic,
             endocrine, or other disease or condition based on information gathered from the
             medical history, physical examination, or laboratory findings that might place the
             subject at undue risk or potentially compromise the results or interpretation of the
             study.

          5. Subject has a history of significant cerebrovascular disease, coronary artery disease,
             or cardiac arrhythmias. Subject has a history (or family history) of congenital
             prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically
             significant electrocardiogram (ECG) at screening, including QTcB (QT interval
             corrected for heart rate using Bazett's formula) value >450 msec (males) or >470 msec
             (females); or shows evidence of clinically significant rhythm abnormality.

          6. Subject has a known hypersensitivity to TD-4208 or similar drug class.

          7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.