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 | Completed Phase 3 FDA Drug

• 1 other identifier: 2019-TIOT-0200-PD-01
• Study Type: interventional
• Target: 335
• Locations: 2 countries
• Sites: 33

Brief Summary

Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve

  Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment

  24 Hours

Study Arms (3)

Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)

EXPERIMENTAL

Combination Product: Test Product - Tiotropium Bromide Inhalation Powder 18 mcg

Treatment B: 18 mcg of Reference Product (Spiriva)

ACTIVE COMPARATOR

Combination Product: Spiriva Handihaler (Tiotropium Bromide) 18 mcg

Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

Test Product - Tiotropium Bromide Inhalation Powder 18 mcg COMBINATION_PRODUCT

Test Product

Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)

Spiriva Handihaler (Tiotropium Bromide) 18 mcg COMBINATION_PRODUCT

RLD

Treatment B: 18 mcg of Reference Product (Spiriva)

Placebo COMBINATION_PRODUCT

Placebo Product

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed informed consent form before initiation of any study related procedure.
• Male or non-pregnant female patients between 40 to 75 years of age at Screening Visit.
• General good health (except the COPD diagnosis) and free of any concomitant conditions or treatment that could interfere with study conduct.
• An established physician diagnosis of COPD (GOLD 2022).
• Post-bronchodilator FEV1≤80% and ≥40% of predicted normal values (GLI-2012), and post-bronchodilator FEV1/FVC ratio ≤0.70.
• Predose FEV1 values at Visits 4 and 5 within ± 20% of the Visit 3 FEV1.
• Able to replace their current short-acting bronchodilators with study-provided albuterol/salbutamol inhalation aerosol provided at the Screening Visit (Visit 1) for use as needed for the duration of the study.
• Patients must be able to discontinue their COPD maintenance medications during the run-in and treatment periods.
• Patients must be able to withhold their short-acting β2-agonists for at least 6 hours prior to spirometry on each clinic visit at the discretion of the investigator.
• Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack-Year= (cigarettes smoked per day x years smoked)/20)).
• Not pregnant , breastfeeding, not a woman of childbearing potential (WOCBP) or WOCBP using an acceptable contraceptive
• No occurrence of an upper or lower respiratory tract infection during the run-in period.
• No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or requiring excessive use of the albuterol/salbutamol rescue medication during the run-in and/or treatment period at the discretion of the Investigator, or the use of antibiotics and/or corticosteroids during the run-in period and/or treatment period.

You may not qualify if:

• Treatment for COPD exacerbation within 12 weeks prior to the Screening Visit or 2 or more exacerbations in the last year.
• Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit.
• History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4.
• Acute upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 8 weeks prior to the Screening Visit.
• Use of immediate-release (Oral or IV) corticosteroids within the last 30 days and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks prior to the Screening Visit
• Patients with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
• Patients with an abnormal/clinically significant 12-lead electrocardiogram (ECG) prior to and during screening visit, during the run-in and treatment periods.
• Patients with myocardial infarction or unstable angina in the last 12 months; unstable or life-threatening cardiac arrhythmia requiring intervention in the last 12 months; or New York Heart Association Class II-IV heart failure.
• Patients with documented pulmonary hypertension or clinical signs of right heart failure (indicated by an increase in jugular venous pressure with or without peripheral edema) or patients who require chronic oxygen use for \>12 hours per day.
• Presence of glaucoma or a history/family history of glaucoma.
• History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, or any other condition, which, in the opinion of the Investigator, would contraindicate the use of an anticholinergic agent.
• Presence or history of urinary retention.
• Historical or current evidence of a clinically significant disease (Note: Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study) including, but not limited to:
• Cardiovascular (e.g., congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, stroke, or non-controlled arrhythmias),
• Hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, and Cushing's syndrome),

Sponsors & Collaborators

• Xiromed LLC: lead
• Exeltis: collaborator
• Laboratorios Liconsa: collaborator

Study Sites (33)

DownTown LA Research (West Coast)

Los Angeles, California, 90017, United States

Location

Southwest General Heathcare

Fort Myers, Florida, 33907, United States

Location

SIMED Health

Gainesville, Florida, 32607, United States

Location

Clinical Research Solutions

Kissimmee, Florida, 34744, United States

Location

Clintex Research Group, Inc.

Miami, Florida, 33145, United States

Location

Research Institue of South Florida

Miami, Florida, 33173, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Velocity Clinical Research - New Smyrna Beach

New Smyrna Beach, Florida, 32132, United States

Location

Southern Clinical Research

Zachary, Louisiana, 70791, United States

Location

Velocity clinical Research Syracuse (East North))

Syracuse, New York, 13057, United States

Location

Velocity Clinical Research-Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research Grants Pass (W Coast)

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Research Medford

Medford, Oregon, 97504, United States

Location

Greater Providence Clinical Research (East North)

Cranston, Rhode Island, 02920, United States

Location

Velocity Clinical Research Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research Columbia

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research Gaffney

Gaffney, South Carolina, 29340, United States

Location

Velocity Clinical Research Greenville

Greenville, South Carolina, 29615, United States

Location

Velocity Clinical Research Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Velocity Clinical Research Union

Union, South Carolina, 29379, United States

Location

Inquest Clinical Research

Cypress, Texas, 77433, United States

Location

Mt. Olympus Medical Research

Houston, Texas, 77479, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Velocity Clinical Research-Utah

West Jordan, Utah, 84088, United States

Location

Anand Surgical Hospital Pvt. Ltd

Ahmedabad, India

Location

Care and Cure Multispeciality Hospital

Ahmedabad, India

Location

Hope Medicare Centre

Ahmedabad, India

Location

Divine Multispeciality Hopsital

Gandhinagar, India

Location

Maharaja Agrasen Superspeciality Hospital

Jaipur, India

Location

Shree Hospital & Critical Care Centre

Nagpur, India

Location

Chest Disease Hospital

Srinagar, India

Location

Global Hospital

Surat, India

Location

Dhawal Multispeciality Hospital

Vadodara, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, single dose, three-way crossover design.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 17, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 14, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

IN (9); US (24)