Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05986591 · View on ClinicalTrials.gov ↗
Study Summary
Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05986591
The ClinicalTrials.gov registry entry for NCT05986591 describes a study currently listed as completed. It is categorized as Phase 3, 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 335 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xiromed, which has 1 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 COPD appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT05986591 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, South Carolina, Oregon. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05986591?
This trial is sponsored by Xiromed, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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