Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD), sponsored by Glenmark Specialty S.A..
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2017-03-24 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 2 |
What the finished NCT03118765 record still lists
NCT03118765 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03118765's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03223610 · 155 participants · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
- NCT05072483 · 155 participants
Natural History Study of CADASIL
- NCT05086497 · 155 participants · NA
WBSI Guided Personalized Delivery of TTFields
- NCT05412069 · 155 participants · NA
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI