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Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover, Multicenter Clinical Study to Assess the Efficacy and Safety of Once Daily Administration of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients With COPD Including a 12-Week Open Label Extension to Assess Inhaler Robustness

NCT03137992•Lupin, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and non-pregnant female subjects (40 years of age and older).
•Patients with diagnosis of COPD according to the GOLD guidelines.
•Post-bronchodilator FEV1 \<80% of the predicted value at the screening visit.
•Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
•Current or former smokers (e.g., with history of = 10 pack-years).
•Written informed consent.

Exclusion Criteria

•Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
•History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
•Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
•Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
•Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
•Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.

Locations (34)

Investigational Research Center Site #1017

Andalusia, Alabama, United States

Investigational Research Center Site #1003

Jasper, Alabama, United States

Investigational Research Center Site #1008

Glendale, Arizona, United States

Investigational Research Center Site #1034

Los Angeles, California, United States

Investigational Research Center Site #1028

Riverside, California, United States

Investigational Research Center Site #1010

Westminster, California, United States

Investigational Research Center Site #1016

Colorado Springs, Colorado, United States

Investigational Research Center Site #1026

Clearwater, Florida, United States

Investigational Research Center Site #1019

Clearwater, Florida, United States

Investigational Research Center Site #1035

Clearwater, Florida, United States

Key Dates

Start Date

November 21, 2017

Primary Completion Date

January 31, 2018

Completion Date

April 30, 2018

Last Updated

April 5, 2021

Enrollment

377

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Placebo

DRUG

Test Product (tiotropium bromide inhalation powder)

DRUG

Reference Product (Spiriva®)

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

View study

RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease