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

NCT03137992 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TB-DPI-301
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 34

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (2)

• Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose

  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

  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

Study Arms (3)

Test Product (tiotropium bromide inhalation powder)

EXPERIMENTAL

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)

Reference Product (Spiriva®)

ACTIVE COMPARATOR

Single dose of reference product (Spiriva®) 18 mcg

Drug: Reference Product (Spiriva®)

Placebo

PLACEBO COMPARATOR

Single dose of placebo inhalation powder

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

Test Product (tiotropium bromide inhalation powder) 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.

Test Product (tiotropium bromide inhalation powder)

Reference Product (Spiriva®) DRUG

Reference product (Spiriva®) 18 mcg.

Reference Product (Spiriva®)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lupin, Inc.: lead

Study Sites (34)

Investigational Research Center Site #1017

Andalusia, Alabama, 36420, United States

Location

Investigational Research Center Site #1003

Jasper, Alabama, 35501, United States

Location

Investigational Research Center Site #1008

Glendale, Arizona, 85306, United States

Location

Investigational Research Center Site #1034

Los Angeles, California, 90025, United States

Location

Investigational Research Center Site #1028

Riverside, California, 92506, United States

Location

Investigational Research Center Site #1010

Westminster, California, 92683, United States

Location

Investigational Research Center Site #1016

Colorado Springs, Colorado, 80907, United States

Location

Investigational Research Center Site #1026

Clearwater, Florida, 33756, United States

Location

Investigational Research Center Site #1019

Clearwater, Florida, 33765, United States

Location

Investigational Research Center Site #1035

Clearwater, Florida, 33765, United States

Location

Investigational Research Center Site #1036

Orlando, Florida, 32825, United States

Location

Investigational Research Center Site #1001

North Dartmouth, Massachusetts, 02747, United States

Location

Investigational Research Center Site #1011

Fridley, Minnesota, 55432, United States

Location

Investigational Research Center Site #1029

St Louis, Missouri, 63141, United States

Location

Investigational Research Center Site #1007

Las Vegas, Nevada, 89119, United States

Location

Investigational Research Center Site #1032

Raleigh, North Carolina, 27607, United States

Location

Investigational Research Center Site #1037

Columbus, Ohio, 43215, United States

Location

Investigational Research Center Site #1018

Edmond, Oklahoma, 73034, United States

Location

Investigational Research Center Site #1009

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Research Center Site #1033

Tulsa, Oklahoma, 74136, United States

Location

Investigational Research Center Site #1005

Medford, Oregon, 97504, United States

Location

Investigational Research Center Site #1006

Portland, Oregon, 97202, United States

Location

Investigational Research Center Site #1015

Easley, South Carolina, 29640, United States

Location

Investigational Research Center Site #1012

Gaffney, South Carolina, 29340, United States

Location

Investigational Research Center Site #1023

Rock Hill, South Carolina, 29732, United States

Location

Investigational Research Center Site #1024

Seneca, South Carolina, 29678, United States

Location

Investigational Research Center Site #1020

Spartanburg, South Carolina, 29303, United States

Location

Investigational Research Center Site #1025

Spartanburg, South Carolina, 29303, United States

Location

Investigational Research Center Site #1027

Union, South Carolina, 29379, United States

Location

Investigational Research Center Site #1004

Knoxville, Tennessee, 37909, United States

Location

Investigational Research Center Site #1013

El Paso, Texas, 79903, United States

Location

Investigational Research Center Site #1002

McKinney, Texas, 75069, United States

Location

Investigational Research Center Site #1030

New Braunfels, Texas, 78130, United States

Location

Investigational Research Center Site #1031

Newport News, Virginia, 23606, United States

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

Results Point of Contact

• Title: Dr. Mark Lepore
• Organization: Lupin Research Inc

marklepore@lupin.com

(443) 740-9323

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, double-dummy, placebo controlled

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 3, 2017
• Study Start: November 21, 2017
• Primary Completion: January 31, 2018
• Study Completion: April 30, 2018
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Locations

US (34)