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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Test Product (tiotropium bromide inhalation powder)
Reference Product (Spiriva®)
Sponsored by
Lupin, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational Research Center Site #1017
  • Investigational Research Center Site #1003
  • Investigational Research Center Site #1008
  • Investigational Research Center Site #1034
  • Investigational Research Center Site #1028
  • Investigational Research Center Site #1010
  • Investigational Research Center Site #1016
  • Investigational Research Center Site #1026
  • Investigational Research Center Site #1019
  • Investigational Research Center Site #1035
  • Investigational Research Center Site #1036
  • Investigational Research Center Site #1001
  • Investigational Research Center Site #1011
  • Investigational Research Center Site #1029
  • Investigational Research Center Site #1007
  • Investigational Research Center Site #1032
  • Investigational Research Center Site #1037
  • Investigational Research Center Site #1018
  • Investigational Research Center Site #1009
  • Investigational Research Center Site #1033
  • Investigational Research Center Site #1005
  • Investigational Research Center Site #1006
  • Investigational Research Center Site #1015
  • Investigational Research Center Site #1012
  • Investigational Research Center Site #1023
  • Investigational Research Center Site #1024
  • Investigational Research Center Site #1020
  • Investigational Research Center Site #1025
  • Investigational Research Center Site #1027
  • Investigational Research Center Site #1004
  • Investigational Research Center Site #1013
  • Investigational Research Center Site #1002
  • Investigational Research Center Site #1030
  • Investigational Research Center Site #1031

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Product (tiotropium bromide inhalation powder)

Reference Product (Spiriva®)

Placebo

Arm Description

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

Single dose of reference product (Spiriva®) 18 mcg

Single dose of placebo inhalation powder

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2017
Last Updated
March 10, 2021
Sponsor
Lupin, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03137992
Brief Title
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lupin, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Double-blind, double-dummy, placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Product (tiotropium bromide inhalation powder)
Arm Type
Experimental
Arm Description
Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).
Arm Title
Reference Product (Spiriva®)
Arm Type
Active Comparator
Arm Description
Single dose of reference product (Spiriva®) 18 mcg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo inhalation powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.
Intervention Type
Drug
Intervention Name(s)
Test Product (tiotropium bromide inhalation powder)
Intervention Description
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
Intervention Name(s)
Reference Product (Spiriva®)
Intervention Description
Reference product (Spiriva®) 18 mcg.
Primary Outcome Measure Information:
Title
Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
Description
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.
Time Frame
0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
Title
Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo
Description
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.
Time Frame
0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigational Research Center Site #1017
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Investigational Research Center Site #1003
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Investigational Research Center Site #1008
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Investigational Research Center Site #1034
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Investigational Research Center Site #1028
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Investigational Research Center Site #1010
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Investigational Research Center Site #1016
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Investigational Research Center Site #1026
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Research Center Site #1019
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Investigational Research Center Site #1035
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Investigational Research Center Site #1036
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Investigational Research Center Site #1001
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Investigational Research Center Site #1011
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Investigational Research Center Site #1029
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Research Center Site #1007
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigational Research Center Site #1032
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Investigational Research Center Site #1037
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Investigational Research Center Site #1018
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Investigational Research Center Site #1009
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Research Center Site #1033
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Investigational Research Center Site #1005
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Research Center Site #1006
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Investigational Research Center Site #1015
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Investigational Research Center Site #1012
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Investigational Research Center Site #1023
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Investigational Research Center Site #1024
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29678
Country
United States
Facility Name
Investigational Research Center Site #1020
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigational Research Center Site #1025
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigational Research Center Site #1027
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Investigational Research Center Site #1004
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Investigational Research Center Site #1013
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Investigational Research Center Site #1002
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Investigational Research Center Site #1030
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Investigational Research Center Site #1031
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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