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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 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.

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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

Conditions Studied

COPD

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

FieldValue
Enrollment Target 335 participants
Start Date 2022-08-17
Est. Completion 2023-08-14
Phase Phase 3

Sponsor

Xiromed

2 total trials

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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, categorized as Phase 3. The registered enrollment target is 335 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 85 other COPD trials with a reported enrollment target (86% lower). The listed sponsor is Xiromed, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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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.