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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Reference Product (Spiriva®) | Active Comparator | Single dose of reference product (Spiriva®) 18 mcg |
|
| Placebo | Placebo Comparator | Single dose of placebo inhalation powder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single dose of placebo inhalation powder administered by test and reference dry powder inhalers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Research Center Site #1017 | Andalusia | Alabama | 36420 | United States | ||
| Investigational Research Center Site #1003 |
Of the 377 participants randomized to treatment groups, three subjects did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A (T-R-P) | Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Spiriva Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Placebo in period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Period 1 (Visit 2) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2018 | Jan 27, 2021 |
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Double-blind, double-dummy, placebo controlled
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Double-blind
| 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. |
|
| Reference Product (Spiriva®) | Drug | Reference product (Spiriva®) 18 mcg. |
|
| Jasper |
| Alabama |
| 35501 |
| United States |
| Investigational Research Center Site #1008 | Glendale | Arizona | 85306 | United States |
| Investigational Research Center Site #1034 | Los Angeles | California | 90025 | United States |
| Investigational Research Center Site #1028 | Riverside | California | 92506 | United States |
| Investigational Research Center Site #1010 | Westminster | California | 92683 | United States |
| Investigational Research Center Site #1016 | Colorado Springs | Colorado | 80907 | United States |
| Investigational Research Center Site #1026 | Clearwater | Florida | 33756 | United States |
| Investigational Research Center Site #1019 | Clearwater | Florida | 33765 | United States |
| Investigational Research Center Site #1035 | Clearwater | Florida | 33765 | United States |
| Investigational Research Center Site #1036 | Orlando | Florida | 32825 | United States |
| Investigational Research Center Site #1001 | North Dartmouth | Massachusetts | 02747 | United States |
| Investigational Research Center Site #1011 | Fridley | Minnesota | 55432 | United States |
| Investigational Research Center Site #1029 | St Louis | Missouri | 63141 | United States |
| Investigational Research Center Site #1007 | Las Vegas | Nevada | 89119 | United States |
| Investigational Research Center Site #1032 | Raleigh | North Carolina | 27607 | United States |
| Investigational Research Center Site #1037 | Columbus | Ohio | 43215 | United States |
| Investigational Research Center Site #1018 | Edmond | Oklahoma | 73034 | United States |
| Investigational Research Center Site #1009 | Oklahoma City | Oklahoma | 73103 | United States |
| Investigational Research Center Site #1033 | Tulsa | Oklahoma | 74136 | United States |
| Investigational Research Center Site #1005 | Medford | Oregon | 97504 | United States |
| Investigational Research Center Site #1006 | Portland | Oregon | 97202 | United States |
| Investigational Research Center Site #1015 | Easley | South Carolina | 29640 | United States |
| Investigational Research Center Site #1012 | Gaffney | South Carolina | 29340 | United States |
| Investigational Research Center Site #1023 | Rock Hill | South Carolina | 29732 | United States |
| Investigational Research Center Site #1024 | Seneca | South Carolina | 29678 | United States |
| Investigational Research Center Site #1020 | Spartanburg | South Carolina | 29303 | United States |
| Investigational Research Center Site #1025 | Spartanburg | South Carolina | 29303 | United States |
| Investigational Research Center Site #1027 | Union | South Carolina | 29379 | United States |
| Investigational Research Center Site #1004 | Knoxville | Tennessee | 37909 | United States |
| Investigational Research Center Site #1013 | El Paso | Texas | 79903 | United States |
| Investigational Research Center Site #1002 | McKinney | Texas | 75069 | United States |
| Investigational Research Center Site #1030 | New Braunfels | Texas | 78130 | United States |
| Investigational Research Center Site #1031 | Newport News | Virginia | 23606 | United States |
| FG001 | Sequence B (R-P-T) | Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by placebo in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
| FG002 | Sequence C (P-T-R) | Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
| FG003 | Sequence D (P-R-T) | Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
| FG004 | Sequence E (T-P-R) | Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Placebo in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
| FG005 | Sequence F (R-T-P) | Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by Placebo in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days |
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| COMPLETED | One subject randomized to Sequence A received treatment P in period 1 (visit 2) |
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| NOT COMPLETED |
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| Washout Period 1 |
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| Period 2 (Visit 3) |
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| Washout Period 2 |
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| Period 3 (Visit 04) |
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| Part 2 (Open-label Extension) |
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All randomized patients who received a dose of any of the study medications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | The safety analysis population included all patients who received at least one dose of any one of the randomized investigational products and for whom data had been collected after randomization. Patient baseline characteristics are not designated by treatment arms due to the crossover design of the study (treatment groups are not mutually exclusive). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline Weight | Mean | Standard Deviation | kilograms |
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| Baseline Height | Mean | Standard Deviation | centimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | L*hour | 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks |
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| 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. | Intention-To-Treat population | Posted | Least Squares Mean | Standard Error | L*hour | 0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks |
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All AEs/SAEs were assessed through study completion, an average of 14 weeks for participants enrolled in only part 1 of the study and 26 weeks for participants enrolled in part 1 and part 2 of the study. AEs were recorded starting after the patient signed the informed consent form and assessed at each visit.
Adverse events are illnesses or signs/symptoms that appear or worsen during the testing of a drug whether o not considered related to the investigational product (synonyms = medicinal or pharmaceutical product, study medication, clinical trial materials, etc.) including side effects, injury, toxicity, or hypersensitivity reactions. AEs were captured during participant interviews during on-site and telephonic visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product (Lupin Tiotropium Bromide Inhalation Powder) | Single dose 18 mcg of test product (tiotropium bromide inhalation powder) for double blind portion. Once daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness). | 0 | 337 | 0 | 337 | 0 | 337 |
| EG001 | Reference Product (Spiriva®) | Single dose of reference product (Spiriva®) 18 mcg Reference Product (Spiriva®): Reference product (Spiriva®) 18 mcg. | 0 | 343 | 0 | 343 | 0 | 343 |
| EG002 | Placebo | Single dose of placebo inhalation powder Placebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers. | 0 | 329 | 0 | 329 | 0 | 329 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Lepore | Lupin Research Inc | (443) 740-9323 | marklepore@lupin.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 11, 2017 | Jan 28, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Withdrawal by Subject |
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| Principal Investigator Discretion |
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| COPD Exacerbation |
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| Subject Noncompliance |
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| Did not meet continuation criteria |
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| Adverse Event |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Subject Non-compliance |
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| Adverse Event |
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| Withdrawal by Subject |
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| Sponsor Decision |
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| Withdrawal by Subject |
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| COPD exacerbation |
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| Per study team |
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| Prohibited Medication |
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| Asian |
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| American Indian/Alaska Native |
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Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.
| Placebo |
Single dose of placebo inhalation powder Placebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers. |
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