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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: GSP304 Placebo Inhalation Solution; Drug: Spiriva® Respimat® inhalation spray; Drug: GSP304 (tiotropium bromide) Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03118765

GSP304-201

Details and patient eligibility

About

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

Enrollment: 155 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

155 participants in 5 patient groups, including a placebo group

Test Treatment T1: GSP304 Inhalation Solution

Experimental group

Treatment:

Drug: GSP304 (tiotropium bromide) Inhalation Solution

Test Treatment T2: GSP304 Inhalation Solution

Experimental group

Treatment:

Drug: GSP304 (tiotropium bromide) Inhalation Solution

Test Treatment T3: GSP304 Inhalation Solution

Experimental group

Treatment:

Drug: GSP304 (tiotropium bromide) Inhalation Solution

Test Treatment T4: GSP304 Placebo Inhalation Solution

Placebo Comparator group

Treatment:

Drug: GSP304 Placebo Inhalation Solution

Test Treatment T5: Spiriva® Respimat® inhalation spray

Active Comparator group

Treatment:

Drug: Spiriva® Respimat® inhalation spray