Chronic Obstructive Pulmonary Disease Clinical Trial
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
| Verified date | March 2021 |
| Source | Lupin Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 377 |
| Est. completion date | April 30, 2018 |
| Est. primary completion date | January 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigational Research Center Site #1017 | Andalusia | Alabama |
| United States | Investigational Research Center Site #1019 | Clearwater | Florida |
| United States | Investigational Research Center Site #1026 | Clearwater | Florida |
| United States | Investigational Research Center Site #1035 | Clearwater | Florida |
| United States | Investigational Research Center Site #1016 | Colorado Springs | Colorado |
| United States | Investigational Research Center Site #1037 | Columbus | Ohio |
| United States | Investigational Research Center Site #1015 | Easley | South Carolina |
| United States | Investigational Research Center Site #1018 | Edmond | Oklahoma |
| United States | Investigational Research Center Site #1013 | El Paso | Texas |
| United States | Investigational Research Center Site #1011 | Fridley | Minnesota |
| United States | Investigational Research Center Site #1012 | Gaffney | South Carolina |
| United States | Investigational Research Center Site #1008 | Glendale | Arizona |
| United States | Investigational Research Center Site #1003 | Jasper | Alabama |
| United States | Investigational Research Center Site #1004 | Knoxville | Tennessee |
| United States | Investigational Research Center Site #1007 | Las Vegas | Nevada |
| United States | Investigational Research Center Site #1034 | Los Angeles | California |
| United States | Investigational Research Center Site #1002 | McKinney | Texas |
| United States | Investigational Research Center Site #1005 | Medford | Oregon |
| United States | Investigational Research Center Site #1030 | New Braunfels | Texas |
| United States | Investigational Research Center Site #1031 | Newport News | Virginia |
| United States | Investigational Research Center Site #1001 | North Dartmouth | Massachusetts |
| United States | Investigational Research Center Site #1009 | Oklahoma City | Oklahoma |
| United States | Investigational Research Center Site #1036 | Orlando | Florida |
| United States | Investigational Research Center Site #1006 | Portland | Oregon |
| United States | Investigational Research Center Site #1032 | Raleigh | North Carolina |
| United States | Investigational Research Center Site #1028 | Riverside | California |
| United States | Investigational Research Center Site #1023 | Rock Hill | South Carolina |
| United States | Investigational Research Center Site #1029 | Saint Louis | Missouri |
| United States | Investigational Research Center Site #1024 | Seneca | South Carolina |
| United States | Investigational Research Center Site #1020 | Spartanburg | South Carolina |
| United States | Investigational Research Center Site #1025 | Spartanburg | South Carolina |
| United States | Investigational Research Center Site #1033 | Tulsa | Oklahoma |
| United States | Investigational Research Center Site #1027 | Union | South Carolina |
| United States | Investigational Research Center Site #1010 | Westminster | California |
| Lead Sponsor | Collaborator |
|---|---|
| Lupin, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
| Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
| Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
| Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
| Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
| Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
| Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
| Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|