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

NCT ID: NCT03137992

Last Updated: 2021-04-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, double-dummy, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double-blind

Study Groups

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Test Product (tiotropium bromide inhalation powder)

Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).

Group Type EXPERIMENTAL

Test Product (tiotropium bromide inhalation powder)

Intervention Type DRUG

Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.

Reference Product (Spiriva®)

Single dose of reference product (Spiriva®) 18 mcg

Group Type ACTIVE_COMPARATOR

Reference Product (Spiriva®)

Intervention Type DRUG

Reference product (Spiriva®) 18 mcg.

Placebo

Single dose of placebo inhalation powder

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.

Interventions

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Placebo

Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.

Intervention Type DRUG

Test Product (tiotropium bromide inhalation powder)

Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.

Intervention Type DRUG

Reference Product (Spiriva®)

Reference product (Spiriva®) 18 mcg.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lupin, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Research Center Site #1017

Andalusia, Alabama, United States

Site Status

Investigational Research Center Site #1003

Jasper, Alabama, United States

Site Status

Investigational Research Center Site #1008

Glendale, Arizona, United States

Site Status

Investigational Research Center Site #1034

Los Angeles, California, United States

Site Status

Investigational Research Center Site #1028

Riverside, California, United States

Site Status

Investigational Research Center Site #1010

Westminster, California, United States

Site Status

Investigational Research Center Site #1016

Colorado Springs, Colorado, United States

Site Status

Investigational Research Center Site #1026

Clearwater, Florida, United States

Site Status

Investigational Research Center Site #1019

Clearwater, Florida, United States

Site Status

Investigational Research Center Site #1035

Clearwater, Florida, United States

Site Status

Investigational Research Center Site #1036

Orlando, Florida, United States

Site Status

Investigational Research Center Site #1001

North Dartmouth, Massachusetts, United States

Site Status

Investigational Research Center Site #1011

Fridley, Minnesota, United States

Site Status

Investigational Research Center Site #1029

St Louis, Missouri, United States

Site Status

Investigational Research Center Site #1007

Las Vegas, Nevada, United States

Site Status

Investigational Research Center Site #1032

Raleigh, North Carolina, United States

Site Status

Investigational Research Center Site #1037

Columbus, Ohio, United States

Site Status

Investigational Research Center Site #1018

Edmond, Oklahoma, United States

Site Status

Investigational Research Center Site #1009

Oklahoma City, Oklahoma, United States

Site Status

Investigational Research Center Site #1033

Tulsa, Oklahoma, United States

Site Status

Investigational Research Center Site #1005

Medford, Oregon, United States

Site Status

Investigational Research Center Site #1006

Portland, Oregon, United States

Site Status

Investigational Research Center Site #1015

Easley, South Carolina, United States

Site Status

Investigational Research Center Site #1012

Gaffney, South Carolina, United States

Site Status

Investigational Research Center Site #1023

Rock Hill, South Carolina, United States

Site Status

Investigational Research Center Site #1024

Seneca, South Carolina, United States

Site Status

Investigational Research Center Site #1020

Spartanburg, South Carolina, United States

Site Status

Investigational Research Center Site #1025

Spartanburg, South Carolina, United States

Site Status

Investigational Research Center Site #1027

Union, South Carolina, United States

Site Status

Investigational Research Center Site #1004

Knoxville, Tennessee, United States

Site Status

Investigational Research Center Site #1013

El Paso, Texas, United States

Site Status

Investigational Research Center Site #1002

McKinney, Texas, United States

Site Status

Investigational Research Center Site #1030

New Braunfels, Texas, United States

Site Status

Investigational Research Center Site #1031

Newport News, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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TB-DPI-301

Identifier Type: -

Identifier Source: org_study_id

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