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

NCT03118765 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2019-08-01

Study results available
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Summary

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

Conditions

  • Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

GSP304 (tiotropium bromide) Inhalation Solution

Once daily (QD) oral inhalation using a nebulizer

DRUG

GSP304 Placebo Inhalation Solution

Once daily (QD) oral inhalation using a nebulizer

DRUG

Spiriva® Respimat® inhalation spray

Once daily (QD) oral inhalation

Sponsors & Collaborators

  • Glenmark Specialty S.A.

    lead INDUSTRY

Principal Investigators

  • Cynthia Caracta, MD FCCP · Glenmark Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2017-07-31
Completion
2017-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118765 on ClinicalTrials.gov