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

• Status: Completed
• Trial end date: 2017-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Specialty S.A.
• Treatments: Bromides; Pharmaceutical Solutions; Tiotropium Bromide

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.