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

March 10, 2021 updated by: Lupin, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
377

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Andalusia, Alabama, United States, 36420
        • Investigational Research Center Site #1017
      • Jasper, Alabama, United States, 35501
        • Investigational Research Center Site #1003
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Investigational Research Center Site #1008
    • California
      • Los Angeles, California, United States, 90025
        • Investigational Research Center Site #1034
      • Riverside, California, United States, 92506
        • Investigational Research Center Site #1028
      • Westminster, California, United States, 92683
        • Investigational Research Center Site #1010
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Investigational Research Center Site #1016
    • Florida
      • Clearwater, Florida, United States, 33756
        • Investigational Research Center Site #1026
      • Clearwater, Florida, United States, 33765
        • Investigational Research Center Site #1019
      • Clearwater, Florida, United States, 33765
        • Investigational Research Center Site #1035
      • Orlando, Florida, United States, 32825
        • Investigational Research Center Site #1036
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Investigational Research Center Site #1001
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Investigational Research Center Site #1011
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Investigational Research Center Site #1029
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Investigational Research Center Site #1007
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Investigational Research Center Site #1032
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Investigational Research Center Site #1037
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Investigational Research Center Site #1018
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Research Center Site #1009
      • Tulsa, Oklahoma, United States, 74136
        • Investigational Research Center Site #1033
    • Oregon
      • Medford, Oregon, United States, 97504
        • Investigational Research Center Site #1005
      • Portland, Oregon, United States, 97202
        • Investigational Research Center Site #1006
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Investigational Research Center Site #1015
      • Gaffney, South Carolina, United States, 29340
        • Investigational Research Center Site #1012
      • Rock Hill, South Carolina, United States, 29732
        • Investigational Research Center Site #1023
      • Seneca, South Carolina, United States, 29678
        • Investigational Research Center Site #1024
      • Spartanburg, South Carolina, United States, 29303
        • Investigational Research Center Site #1020
      • Spartanburg, South Carolina, United States, 29303
        • Investigational Research Center Site #1025
      • Union, South Carolina, United States, 29379
        • Investigational Research Center Site #1027
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Investigational Research Center Site #1004
    • Texas
      • El Paso, Texas, United States, 79903
        • Investigational Research Center Site #1013
      • McKinney, Texas, United States, 75069
        • Investigational Research Center Site #1002
      • New Braunfels, Texas, United States, 78130
        • Investigational Research Center Site #1030
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Investigational Research Center Site #1031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Product (tiotropium bromide inhalation powder)
Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).
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.
Active Comparator: Reference Product (Spiriva®)
Single dose of reference product (Spiriva®) 18 mcg
Drug: Reference Product (Spiriva®)
Reference product (Spiriva®) 18 mcg.
Placebo Comparator: Placebo
Single dose of placebo inhalation powder
Drug: Placebo
Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
Time Frame: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
To show clinical bioequivalence in the efficacy of the test product as a single dose versus reference product based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.
0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo
Time Frame: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
This measure is to demonstrate that test product as a single dose and reference product are superior to placebo based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.
0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lupin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB-DPI-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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