Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: GSP304 (tiotropium bromide) Inhalation Solution; GSP304 Placebo Inhalation Solution; Spiriva® Respimat® inhalation spray
Intervention description: Once daily (QD) oral inhalation using a nebulizer; Once daily (QD) oral inhalation using a nebulizer; Once daily (QD) oral inhalation
Intervention MeSH terms: Bromides; Pharmaceutical Solutions; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via
      Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥40 years and ≤85 years of age at the time of consent.

          -  Subject must have a primary diagnosis of mild or moderate COPD defined as
             post-bronchodilator FEV1/FVC ratio of <70% and FEV1 of ≥50% of predicted normal value
             as per the NHANES III predicted normal values at screening.

          -  Willing to stop all other COPD medications or other medications which will interfere
             with the study results for the entire duration of the study, except
             albuterol/salbutamol as needed.

          -  Current or ex-smoker with ≥10 pack-year smoking history.

        Exclusion Criteria:

          -  Subjects with a chest x-ray/CT scan that suggests a diagnosis other than COPD (eg,
             pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing
             pulmonary conditions) and taken within 6 months prior to study start. If there is no
             chest x-ray or CT scan taken within 6 months prior to study start, or if recent
             results are unavailable for review, a chest x-ray must be performed.

          -  Use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot
             corticosteroids within 3 months prior to screening or subject has had a change in dose
             or type of any medications for COPD within 14 days before screening.

          -  Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening.

          -  Subjects with a history of asthma, with the exception of outgrown childhood asthma,
             defined as transient wheezers outgrown by 5 years of age.

          -  Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.

          -  Subject requires nocturnal oxygen or continuous supplemental oxygen therapy.

          -  Subject with history of a positive result for HBsAg or HCV antibody.

          -  Subject is known to be seropositive for human immunodeficiency virus.

          -  Female subject is pregnant or lactating.

          -  Subject has a history of allergic reaction to the anti-cholinergic or any components
             of the study medications.