Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; TD-4208 700 μg; TD-4208 350 μg; Ipratropium 500 μg
Intervention MeSH terms: Ipratropium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and
      completed the follow-up assessments. During each of the four study periods, subjects were
      admitted to the clinic on Day -1 and housed overnight until after the last spirometry
      measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples
      collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after
      evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate stable Chronic Obstructive Pulmonary.

          -  Disease with FEV1/FVC <0.7 at screening.

          -  Woman of non-childbearing potential.

          -  Female participants of childbearing potential must test negative for pregnancy and
             must be using a highly effective method of birth control during the study and for at
             least 1 month after completion of study dosing.

          -  Female participants must not be breastfeeding.

          -  Men 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.

          -  Current or past smoking history >10 pack-years.

          -  Must be capable of performing reproducible spirometry maneuvers.

        Exclusion Criteria:

          -  History of significant respiratory disease other than COPD, and/ or requires daily
             long-term oxygen therapy.

          -  Exacerbation of COPD, lung infection within 6 weeks prior to study.

          -  Start of or change in dose of COPD treatment 4 weeks before study.

          -  Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of
             fluticasone propionate equivalent or >5 mg prednisone).

          -  Use of bronchodilators or medication for the treatment of COPD, aspirin,
             anti-inflammatories for a specific time, prior to the first dose or is not willing to
             abstain from their use for the specified time periods prior to study dose
             administration.

          -  Symptomatic prostrate hypertrophy, bladder neck obstruction, active cancer, narrow
             angle glaucoma.

          -  Clinical significant hypersensitivity to medications.

          -  Participants have an uncontrolled hematologic, immunologic, renal, neurologic,
             hepatic, endocrine or other disease that may place participant at risk.

          -  Cerebrovascular, cardiovascular disease or abnormal ECG.

          -  History of drug or alcohol abuse.