Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05986591 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study of COPD, sponsored by Xiromed.
- Completed
- Registry status
- Phase 3
- Development phase
- 335
- Enrollment target
- 20
- Study locations
NCT05986591: Completed Phase 3 study of COPD, sponsored by Xiromed.
NCT05986591 is a Phase 3 study of COPD that has completed, run by Xiromed. The registered enrollment target is 335 participants, below the 2,414-participant average among 85 other COPD trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05986591, a Phase 3 study of COPD, has completed, sponsored by Xiromed.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 335 participants
- Enrollment target
- 20
- Study locations
Study Summary
Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
Primary Outcome
Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT Test Product - Tiotropium Bromide Inhalation Powder 18 mcg
- COMBINATION_PRODUCT Spiriva Handihaler (Tiotropium Bromide) 18 mcg
Study Locations (20)
Florida
- Southwest General Heathcare - Fort Myers
- SIMED Health - Gainesville
- Clinical Research Solutions - Kissimmee
- Clintex Research Group, Inc. - Miami
- Research Institue of South Florida - Miami
- Vista Health Research - Miami
- Velocity Clinical Research - New Smyrna Beach - New Smyrna Beach
South Carolina
- Velocity Clinical Research Anderson - Anderson
- Velocity Clinical Research Columbia - Columbia
- Velocity Clinical Research Gaffney - Gaffney
- Velocity Clinical Research Greenville - Greenville
- Velocity Clinical Research Spartanburg - Spartanburg
- Velocity Clinical Research Union - Union
Oregon
- Velocity Clinical Research Grants Pass (W Coast) - Grants Pass
- Velocity Clinical Research Medford - Medford
California
- DownTown LA Research (West Coast) - Los Angeles
Louisiana
- Southern Clinical Research - Zachary
New York
- Velocity clinical Research Syracuse (East North)) - Syracuse
Ohio
- Velocity Clinical Research-Cincinnati - Cincinnati
Rhode Island
- Greater Providence Clinical Research (East North) - Cranston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2022-08-17 |
| Est. Completion | 2023-08-14 |
| Phase | Phase 3 |
What the finished NCT05986591 record still lists
NCT05986591 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 2,414-participant average among 85 other COPD trials with a reported enrollment target (86% lower).
The record links to 1 condition, with COPD appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05986591 names 20 study sites across 8 states, led by Florida, South Carolina, Oregon.
Frequently Asked Questions
What is clinical trial NCT05986591 about?
NCT05986591 is a clinical study titled "Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)". Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
What is the current status of trial NCT05986591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 335 participants. The study started on 2022-08-17. Estimated completion is 2023-08-14.
What conditions does trial NCT05986591 study?
This clinical trial studies the following conditions: COPD.
What interventions are being tested in trial NCT05986591?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Test Product - Tiotropium Bromide Inhalation Powder 18 mcg (COMBINATION_PRODUCT), Spiriva Handihaler (Tiotropium Bromide) 18 mcg (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05986591?
This trial is sponsored by Xiromed, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05986591 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COPD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05986591's enrollment target sits among peer trials
335 21st of 85 higher than 65 of 85 other COPD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COPD 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
-
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
COMPLETED · Phase 3
-
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
COMPLETED · Phase 3
-
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
RECRUITING · NA
-
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
RECRUITING · NA
-
Pulmonary Hypertension SOLAR
RECRUITING · Phase 2
-
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
RECRUITING · Phase 1
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
- NCT04134754 · 335 participants · NA
Carbon Dioxide (CO2) Chemosensitivity and SUDEP
- NCT05554406 · 335 participants · Phase 2
Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
- NCT06183437 · 335 participants · Phase 4
The STOP-MED CTRCD Trial
- NCT06885177 · 335 participants · NA
TECTONIC CAD IVL IDE Study
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