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

NCT02175342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-01-31

No results posted yet for this study

Summary

This pharmacodynamic and pharmacokinetic dose-ranging study aims to determine the optimal dose of tiotropium inhaled as a solution from a Respimat device once a day for three weeks in patients with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium 0.625 mcg/puff

DRUG

Tiotropium 1.25 mcg/puff

DRUG

Tiotropium 2.5 mcg/puff

DRUG

Tiotropium 5 mcg/puff

DRUG

Placebo solution

DRUG

Tiotropium-18 lactose powder

DRUG

Placebo lactose powder

DRUG

Tiotropium 10 mcg/puff

DEVICE

Respimat

DEVICE

Handihaler

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-01
Primary Completion
1999-04-01

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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 NCT02175342 on ClinicalTrials.gov