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)
NCT ID: NCT05986591
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
335 participants
INTERVENTIONAL
2022-08-17
2023-08-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
NCT05161156
A Trial to Assess the Bioequivalence of Tiotropium Bromide Inhalation Powder in Healthy Adult Participants Under Fasting Conditions
NCT06487416
To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01785433
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
NCT00281567
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02175342
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)
Test Product - Tiotropium Bromide Inhalation Powder 18 mcg
Test Product
Treatment B: 18 mcg of Reference Product (Spiriva)
Spiriva Handihaler (Tiotropium Bromide) 18 mcg
RLD
Placebo
Placebo
Placebo Product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Test Product - Tiotropium Bromide Inhalation Powder 18 mcg
Test Product
Spiriva Handihaler (Tiotropium Bromide) 18 mcg
RLD
Placebo
Placebo Product
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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),
* Gastrointestinal (e.g., poorly-controlled peptic ulcer disease),
* Pulmonary disease other than COPD (e.g., alpha-1 antitrypsin deficiency, active bronchiectasis, cystic fibrosis, broncho-pulmonary dysplasia, sarcoidosis, lung fibrosis, pulmonary edema, interstitial lung disease, lung or mediastinum proliferative process including malignancies).
* Patients who have undergone thoracotomy with pulmonary resection, have plans to undergo lung transplantation or lung volume reduction therapy, or have had lung volume reduction surgery within 12 months prior to the Screening Visit.
* Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the patient, including but not limited to:
* Current malignancy excluding basal cell carcinoma. (Note: History of malignancy is acceptable only if the patient has been in remission for one year prior to the Screening Visit. Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 5 years prior to the Screening Visit.
* Current or untreated tuberculosis (Note: History of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years).
* Uncontrolled hypertension (systolic blood pressure \[BP\] ≥160 or diastolic BP \>100).
* Stroke within 12 months prior to the Screening Visit
* Immunocompromised
* History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives (e.g., ipratropium, oxitropium), or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
* History of alcohol or drug abuse within 2 years prior to the Screening Visit (Visit 1).
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Exeltis
INDUSTRY
Laboratorios Liconsa
INDUSTRY
Xiromed LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
DownTown LA Research (West Coast)
Los Angeles, California, United States
Southwest General Heathcare
Fort Myers, Florida, United States
SIMED Health
Gainesville, Florida, United States
Clinical Research Solutions
Kissimmee, Florida, United States
Clintex Research Group, Inc.
Miami, Florida, United States
Research Institue of South Florida
Miami, Florida, United States
Vista Health Research
Miami, Florida, United States
Velocity Clinical Research - New Smyrna Beach
New Smyrna Beach, Florida, United States
Southern Clinical Research
Zachary, Louisiana, United States
Velocity clinical Research Syracuse (East North))
Syracuse, New York, United States
Velocity Clinical Research-Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research Grants Pass (W Coast)
Grants Pass, Oregon, United States
Velocity Clinical Research Medford
Medford, Oregon, United States
Greater Providence Clinical Research (East North)
Cranston, Rhode Island, United States
Velocity Clinical Research Anderson
Anderson, South Carolina, United States
Velocity Clinical Research Columbia
Columbia, South Carolina, United States
Velocity Clinical Research Gaffney
Gaffney, South Carolina, United States
Velocity Clinical Research Greenville
Greenville, South Carolina, United States
Velocity Clinical Research Spartanburg
Spartanburg, South Carolina, United States
Velocity Clinical Research Union
Union, South Carolina, United States
Inquest Clinical Research
Cypress, Texas, United States
Mt. Olympus Medical Research
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Velocity Clinical Research-Utah
West Jordan, Utah, United States
Anand Surgical Hospital Pvt. Ltd
Ahmedabad, , India
Care and Cure Multispeciality Hospital
Ahmedabad, , India
Hope Medicare Centre
Ahmedabad, , India
Divine Multispeciality Hopsital
Gandhinagar, , India
Maharaja Agrasen Superspeciality Hospital
Jaipur, , India
Shree Hospital & Critical Care Centre
Nagpur, , India
Chest Disease Hospital
Srinagar, , India
Global Hospital
Surat, , India
Dhawal Multispeciality Hospital
Vadodara, , India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-TIOT-0200-PD-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.