Clinical trial NCT03137992: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Lupin Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 377
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, double-dummy, placebo controlled
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose
timeFrame: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
measure: Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo
timeFrame: 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Investigational Research Center Site #1017
state: Alabama
city: Jasper
country: United States
facility: Investigational Research Center Site #1003
state: Alabama
city: Glendale
country: United States
facility: Investigational Research Center Site #1008
state: Arizona
city: Los Angeles
country: United States
facility: Investigational Research Center Site #1034
state: California
city: Riverside
country: United States
facility: Investigational Research Center Site #1028
state: California
city: Westminster
country: United States
facility: Investigational Research Center Site #1010
state: California
city: Colorado Springs
country: United States
facility: Investigational Research Center Site #1016
state: Colorado
city: Clearwater
country: United States
facility: Investigational Research Center Site #1026
state: Florida
city: Clearwater
country: United States
facility: Investigational Research Center Site #1019
state: Florida
city: Clearwater
country: United States
facility: Investigational Research Center Site #1035
state: Florida
city: Orlando
country: United States
facility: Investigational Research Center Site #1036
state: Florida
city: North Dartmouth
country: United States
facility: Investigational Research Center Site #1001
state: Massachusetts
city: Fridley
country: United States
facility: Investigational Research Center Site #1011
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Research Center Site #1029
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Research Center Site #1007
state: Nevada
city: Raleigh
country: United States
facility: Investigational Research Center Site #1032
state: North Carolina
city: Columbus
country: United States
facility: Investigational Research Center Site #1037
state: Ohio
city: Edmond
country: United States
facility: Investigational Research Center Site #1018
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Research Center Site #1009
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Research Center Site #1033
state: Oklahoma
city: Medford
country: United States
facility: Investigational Research Center Site #1005
state: Oregon
city: Portland
country: United States
facility: Investigational Research Center Site #1006
state: Oregon
city: Easley
country: United States
facility: Investigational Research Center Site #1015
state: South Carolina
city: Gaffney
country: United States
facility: Investigational Research Center Site #1012
state: South Carolina
city: Rock Hill
country: United States
facility: Investigational Research Center Site #1023
state: South Carolina
city: Seneca
country: United States
facility: Investigational Research Center Site #1024
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Research Center Site #1020
state: South Carolina
city: Spartanburg
country: United States
facility: Investigational Research Center Site #1025
state: South Carolina
city: Union
country: United States
facility: Investigational Research Center Site #1027
state: South Carolina
city: Knoxville
country: United States
facility: Investigational Research Center Site #1004
state: Tennessee
city: El Paso
country: United States
facility: Investigational Research Center Site #1013
state: Texas
city: McKinney
country: United States
facility: Investigational Research Center Site #1002
state: Texas
city: New Braunfels
country: United States
facility: Investigational Research Center Site #1030
state: Texas
city: Newport News
country: United States
facility: Investigational Research Center Site #1031
state: Virginia
Study officials:
References: