Back to resultsPharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GSP304 (tiotropium bromide) Inhalation Solution
GSP304 Placebo Inhalation Solution
Spiriva® Respimat® inhalation spray
Sponsored by
About this trial
This is an interventional treatment trial for Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects ≥40 years and ≤85 years of age at the time of consent.
- 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:
- Subjects with a chest x-ray/CT scan that suggests a diagnosis other than COPD (eg, pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. If there is no chest x-ray or CT scan taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed.
- 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.
Sites / Locations
- Glenmark Investigational Site 23
- Glenmark Investigational Site 12
- Glenmark Investigational Site 14
- Glenmark Investigational Site 17
- Glenmark Investigational Site 19
- Glenmark Investigational Site 10
- Glenmark Investigational Site 24
- Glenmark Investigational Site 16
- Glenmark Investigational Site 6
- Glenmark Investigational Site 20
- Glenmark Investigational Site 21
- Glenmark Investigational Site 13
- Glenmark Investigational Site 18
- Glenmark Investigational Site 9
- Glenmark Investigational Site 5
- Glenmark Investigational Site 22
- Glenmark Investigational Site 8
- Glenmark Investigational Site 11
- Glenmark Investigational Site 3
- Glenmark Investigational Site 2
- Glenmark Investigational Site 4
- Glenmark Investigational Site 1
- Glenmark Investigational Site 15
- Glenmark Investigational Site 7
- Glenmark Investigational Site 25
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
Test Treatment T1: GSP304 Inhalation Solution
Test Treatment T2: GSP304 Inhalation Solution
Test Treatment T3: GSP304 Inhalation Solution
Test Treatment T4: GSP304 Placebo Inhalation Solution
Test Treatment T5: Spiriva® Respimat® inhalation spray
Arm Description
Outcomes
Primary Outcome Measures
Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS
The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)
Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS
The PK endpoint in plasma to assess the relative bioavailability was area under the plasma concentration-time curve of tiotropium over the dosing interval at steady state (AUC0-tauSS)
Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.
Change from baseline (Day 1) at Day 21 (Week 3) in trough FEV1 response at approximately 24 hours after the last dose (average of 23 hours 15 minutes and 23 hours 45 minutes postdose measurements), in comparison with placebo.
Secondary Outcome Measures
Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of tiotropium excreted in urine over the dosing interval on Day 1
Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
Descriptive statistics for tiotropium urine PK parameter - Fraction of dose (Fe) of tiotropium excreted in urine over the dosing interval on Day 1
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Descriptive statistics for tiotropium urine PK parameter-Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Peak Concentrations During the Dosing Interval (Cmax) on Day 1
Descriptive statistics for tiotropium plasma PK parameters - (Cmax) on Day 1
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1
Descriptive statistics for tiotropium plasma PK parameter - Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) on Day 1
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1
Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 1
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21
Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 21
Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 21
Descriptive statistics for tiotropium plasma PK parameter - Average concentration during a dosing interval at steady state (CavSS) on day 21
Accumulation Ratio Rac(Auc)
Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(auc). Rac(auc) was calculated as AUC0-tauSS/AUC0-tau.
Accumulation Ratio Rac(Cmax)
Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(cmax). Rac(Cmax) was calculated as CmaxSS/Cmax.
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1
The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 1. Change from baseline in peak FEV1 within 12 hours postdose on Day 1 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21
The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 21. Change from baseline in peak FEV1 within 12 hours postdose on Day 21 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.
Change From Baseline in Forced Vital Capacity (FVC) on Day 1
Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 1.
Change From Baseline in Forced Vital Capacity (FVC) on Day 21
Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 21
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1
Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 measured over 12 hours on Day 1.
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21
Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 Measured Over 12 Hours on Day 21.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03118765
Brief Title
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Dose Ranging, Parallel Group, Active (Spiriva® Respimat®) And Placebo Controlled Study To Assess Relative Bioavailability, Pharmacodynamics And Safety Of Three Doses Of Tiotropium Bromide Inhalation Solution In Subjects With Mild To Moderate Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Specialty S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Treatment T1: GSP304 Inhalation Solution
Arm Type
Experimental
Arm Title
Test Treatment T2: GSP304 Inhalation Solution
Arm Type
Experimental
Arm Title
Test Treatment T3: GSP304 Inhalation Solution
Arm Type
Experimental
Arm Title
Test Treatment T4: GSP304 Placebo Inhalation Solution
Arm Type
Placebo Comparator
Arm Title
Test Treatment T5: Spiriva® Respimat® inhalation spray
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GSP304 (tiotropium bromide) Inhalation Solution
Intervention Description
Once daily (QD) oral inhalation using a nebulizer
Intervention Type
Drug
Intervention Name(s)
GSP304 Placebo Inhalation Solution
Intervention Description
Once daily (QD) oral inhalation using a nebulizer
Intervention Type
Drug
Intervention Name(s)
Spiriva® Respimat® inhalation spray
Intervention Description
Once daily (QD) oral inhalation
Primary Outcome Measure Information:
Title
Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS
Description
The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)
Time Frame
Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.
Title
Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS
Description
The PK endpoint in plasma to assess the relative bioavailability was area under the plasma concentration-time curve of tiotropium over the dosing interval at steady state (AUC0-tauSS)
Time Frame
Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.
Title
Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.
Description
Change from baseline (Day 1) at Day 21 (Week 3) in trough FEV1 response at approximately 24 hours after the last dose (average of 23 hours 15 minutes and 23 hours 45 minutes postdose measurements), in comparison with placebo.
Time Frame
21 days (Pre- dose trough FEV1 is mean FEV1 at -45 mins and -15 mins pre-morning dose at Day 1. Trough FEV1 is mean FEV1 obtained 23 hrs 15 mins and 23 hrs 45 mins post-morning dose of day 21).
Secondary Outcome Measure Information:
Title
Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
Description
Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of tiotropium excreted in urine over the dosing interval on Day 1
Time Frame
Day 1
Title
Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Description
Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Time Frame
Day 21
Title
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1
Description
Descriptive statistics for tiotropium urine PK parameter - Fraction of dose (Fe) of tiotropium excreted in urine over the dosing interval on Day 1
Time Frame
Day 1
Title
Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Description
Descriptive statistics for tiotropium urine PK parameter-Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21
Time Frame
Day 21
Title
Peak Concentrations During the Dosing Interval (Cmax) on Day 1
Description
Descriptive statistics for tiotropium plasma PK parameters - (Cmax) on Day 1
Time Frame
Day 1
Title
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1
Description
Descriptive statistics for tiotropium plasma PK parameter - Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) on Day 1
Time Frame
Day 1
Title
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1
Description
Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 1
Time Frame
Day 1
Title
Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21
Description
Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 21
Time Frame
Day 21
Title
Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 21
Description
Descriptive statistics for tiotropium plasma PK parameter - Average concentration during a dosing interval at steady state (CavSS) on day 21
Time Frame
Day 21
Title
Accumulation Ratio Rac(Auc)
Description
Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(auc). Rac(auc) was calculated as AUC0-tauSS/AUC0-tau.
Time Frame
Day 21
Title
Accumulation Ratio Rac(Cmax)
Description
Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(cmax). Rac(Cmax) was calculated as CmaxSS/Cmax.
Time Frame
Day 21
Title
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1
Description
The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 1. Change from baseline in peak FEV1 within 12 hours postdose on Day 1 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.
Time Frame
Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Title
Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21
Description
The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 21. Change from baseline in peak FEV1 within 12 hours postdose on Day 21 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.
Time Frame
Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Title
Change From Baseline in Forced Vital Capacity (FVC) on Day 1
Description
Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 1.
Time Frame
Day 1 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 1. Postdose timing were relative to the end of dosing.The window for 1 hour spirometry and thereafter was ±5 minutes).
Title
Change From Baseline in Forced Vital Capacity (FVC) on Day 21
Description
Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 21
Time Frame
Day 21 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 21. Postdose timing were relative to the end of dosing. The window for 1 hour spirometry and thereafter was ±5 minutes).
Title
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1
Description
Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 measured over 12 hours on Day 1.
Time Frame
Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
Title
Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21
Description
Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 Measured Over 12 Hours on Day 21.
Time Frame
Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects ≥40 years and ≤85 years of age at the time of consent.
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:
Subjects with a chest x-ray/CT scan that suggests a diagnosis other than COPD (eg, pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. If there is no chest x-ray or CT scan taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Caracta, MD FCCP
Organizational Affiliation
Glenmark Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Investigational Site 23
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Glenmark Investigational Site 12
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Glenmark Investigational Site 14
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Glenmark Investigational Site 17
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Glenmark Investigational Site 19
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Glenmark Investigational Site 10
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Glenmark Investigational Site 24
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Glenmark Investigational Site 16
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Glenmark Investigational Site 6
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Glenmark Investigational Site 20
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32124
Country
United States
Facility Name
Glenmark Investigational Site 21
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Glenmark Investigational Site 13
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Glenmark Investigational Site 18
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Glenmark Investigational Site 9
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Glenmark Investigational Site 5
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Glenmark Investigational Site 22
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Glenmark Investigational Site 8
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Glenmark Investigational Site 11
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-9741
Country
United States
Facility Name
Glenmark Investigational Site 3
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Glenmark Investigational Site 2
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Glenmark Investigational Site 4
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Glenmark Investigational Site 1
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Glenmark Investigational Site 15
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Glenmark Investigational Site 7
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Glenmark Investigational Site 25
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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