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NCT03118765 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD), sponsored by Glenmark Specialty S.A..

Completed
Registry status
Phase 2
Development phase
155
Enrollment target
20
Study locations

NCT03118765 is a Phase 2 study of Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 155 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT03118765, a Phase 2 study of Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Glenmark Specialty S.A..

COMPLETED
Registry status
Phase 2
Development phase
155 participants
Enrollment target
20
Study locations

Study Summary

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

Interventions

  • DRUG GSP304 (tiotropium bromide) Inhalation Solution
  • DRUG GSP304 Placebo Inhalation Solution
  • DRUG Spiriva® Respimat® inhalation spray

Study Locations (20)

Florida

  • Glenmark Investigational Site 19 - Edgewater
  • Glenmark Investigational Site 24 - Miami
  • Glenmark Investigational Site 16 - Miami
  • Glenmark Investigational Site 10 - Miami Lakes
  • Glenmark Investigational Site 6 - Orlando
  • Glenmark Investigational Site 20 - Ormond Beach
  • Glenmark Investigational Site 21 - Vero Beach
  • Glenmark Investigational Site 13 - Winter Park

Ohio

  • Glenmark Investigational Site 5 - Columbus
  • Glenmark Investigational Site 22 - Columbus
  • Glenmark Investigational Site 8 - Dublin

Arizona

  • Glenmark Investigational Site 12 - Phoenix
  • Glenmark Investigational Site 14 - Tempe

South Carolina

  • Glenmark Investigational Site 3 - Easley
  • Glenmark Investigational Site 2 - Greenville

Alabama

  • Glenmark Investigational Site 23 - Andalusia

California

  • Glenmark Investigational Site 17 - Fullerton

Nevada

  • Glenmark Investigational Site 18 - Las Vegas

North Carolina

  • Glenmark Investigational Site 9 - Charlotte

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2017-03-24
Est. Completion 2017-07-31
Phase Phase 2

Sponsor

Glenmark Specialty S.A.

6 total trials

What the Registry Record Tells You About NCT03118765

The ClinicalTrials.gov registry entry for NCT03118765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glenmark Specialty S.A., which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 3 interventions - of which GSP304 (tiotropium bromide) Inhalation Solution is the first listed.

NCT03118765 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, Ohio, Arizona.

Frequently Asked Questions

What is clinical trial NCT03118765 about?

NCT03118765 is a clinical study titled "Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)". Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).

What is the current status of trial NCT03118765?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2017-03-24. Estimated completion is 2017-07-31.

What conditions does trial NCT03118765 study?

This clinical trial studies the following conditions: Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD).

What interventions are being tested in trial NCT03118765?

The interventions under investigation include: GSP304 (tiotropium bromide) Inhalation Solution (DRUG), GSP304 Placebo Inhalation Solution (DRUG), Spiriva® Respimat® inhalation spray (DRUG).

Who is sponsoring clinical trial NCT03118765?

This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03118765 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.