Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT03118765 · View on ClinicalTrials.gov ↗

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.

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03118765

The ClinicalTrials.gov registry entry for NCT03118765 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03118765 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Ohio, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03118765?

This trial is sponsored by Glenmark Specialty S.A., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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