Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT03118765
Last Updated: 2019-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2017-03-24
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test Treatment T1: GSP304 Inhalation Solution
GSP304 (tiotropium bromide) Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
Test Treatment T2: GSP304 Inhalation Solution
GSP304 (tiotropium bromide) Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
Test Treatment T3: GSP304 Inhalation Solution
GSP304 (tiotropium bromide) Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
Test Treatment T4: GSP304 Placebo Inhalation Solution
GSP304 Placebo Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
Test Treatment T5: Spiriva® Respimat® inhalation spray
Spiriva® Respimat® inhalation spray
Once daily (QD) oral inhalation
Interventions
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GSP304 (tiotropium bromide) Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
GSP304 Placebo Inhalation Solution
Once daily (QD) oral inhalation using a nebulizer
Spiriva® Respimat® inhalation spray
Once daily (QD) oral inhalation
Eligibility Criteria
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Inclusion Criteria
* Subject must have a primary diagnosis of mild or moderate COPD defined as post-bronchodilator FEV1/FVC ratio of \<70% and FEV1 of ≥50% of predicted normal value as per the NHANES III predicted normal values at screening.
* Willing to stop all other COPD medications or other medications which will interfere with the study results for the entire duration of the study, except albuterol/salbutamol as needed.
* Current or ex-smoker with ≥10 pack-year smoking history.
Exclusion Criteria
* Use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot corticosteroids within 3 months prior to screening or subject has had a change in dose or type of any medications for COPD within 14 days before screening.
* Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening.
* Subjects with a history of asthma, with the exception of outgrown childhood asthma, defined as transient wheezers outgrown by 5 years of age.
* Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
* Subject requires nocturnal oxygen or continuous supplemental oxygen therapy.
* Subject with history of a positive result for HBsAg or HCV antibody.
* Subject is known to be seropositive for human immunodeficiency virus.
* Female subject is pregnant or lactating.
* Subject has a history of allergic reaction to the anti-cholinergic or any components of the study medications.
40 Years
85 Years
ALL
No
Sponsors
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Glenmark Specialty S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Caracta, MD FCCP
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals
Locations
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Glenmark Investigational Site 23
Andalusia, Alabama, United States
Glenmark Investigational Site 12
Phoenix, Arizona, United States
Glenmark Investigational Site 14
Tempe, Arizona, United States
Glenmark Investigational Site 17
Fullerton, California, United States
Glenmark Investigational Site 19
Edgewater, Florida, United States
Glenmark Investigational Site 24
Miami, Florida, United States
Glenmark Investigational Site 16
Miami, Florida, United States
Glenmark Investigational Site 10
Miami Lakes, Florida, United States
Glenmark Investigational Site 6
Orlando, Florida, United States
Glenmark Investigational Site 20
Ormond Beach, Florida, United States
Glenmark Investigational Site 21
Vero Beach, Florida, United States
Glenmark Investigational Site 13
Winter Park, Florida, United States
Glenmark Investigational Site 18
Las Vegas, Nevada, United States
Glenmark Investigational Site 9
Charlotte, North Carolina, United States
Glenmark Investigational Site 5
Columbus, Ohio, United States
Glenmark Investigational Site 22
Columbus, Ohio, United States
Glenmark Investigational Site 8
Dublin, Ohio, United States
Glenmark Investigational Site 11
Medford, Oregon, United States
Glenmark Investigational Site 3
Easley, South Carolina, United States
Glenmark Investigational Site 2
Greenville, South Carolina, United States
Glenmark Investigational Site 4
Greenville, South Carolina, United States
Glenmark Investigational Site 1
Rock Hill, South Carolina, United States
Glenmark Investigational Site 15
Spartanburg, South Carolina, United States
Glenmark Investigational Site 7
Spartanburg, South Carolina, United States
Glenmark Investigational Site 25
Tomball, Texas, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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GSP304-201
Identifier Type: -
Identifier Source: org_study_id
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