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The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT001 MDI (Dose 1) | Experimental |
| |
| PT001 MDI (Dose 2) | Experimental |
| |
| PT001 MDI (Dose 3) | Experimental |
| |
| PT001 MDI (Dose 4) | Experimental |
| |
| PT001 MDI (Dose 5) | Experimental |
| |
| PT001 MDI (Dose 6) | Experimental |
| |
| PT001 Placebo MDI | Placebo Comparator |
| |
| Spiriva® Handihaler® (Tiotropium Bromide) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT001 MDI | Drug | Administered as two puffs BID for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 AUC0-12 | Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days. | Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Change From Baseline in FEV1 | Highest value of FEV1 post dose on day 1 | Day 1 |
| Time to Onset of Action (>10% Improvement in FEV1) on Day 1 | Time to Onset of Action (>10% Improvement in FEV1) on Day 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria as defined in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, MD | Pearl Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Fullerton | California | 92835 | United States | ||
| Pearl Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27586537 | Derived | Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4. |
| Label | URL |
|---|---|
| protocol-pt001003\_FINAL\_Redacted | View source |
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A randomized, double-blind,chronic dosing, four-period, eight-treatment, placebo-controlled, incomplete block, crossover, multicenter study.
The study was conducted at 10 sites in the US from April 2012 to August 2012. Study participation maximum of 26 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Tiotropium Bromide | Drug | Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI |
|
|
| PT001 Placebo MDI | Drug |
|
| Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs) |
| Percentage of Subjects Achieving at Least 12% Improvement in FEV1 | Percentage of subjects achieving at least 12% improvement in FEV1. | Day 1 |
| Peak Change From Baseline in Inspiratory Capacity (IC) | Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline | Day 1 (1 hr and 2 hr post-dose ) |
| Change From Baseline in Morning Pre-dose Trough FEV1 | Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline) | Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline) |
| Peak Change From Baseline in FEV1 | Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline) | Day 7 |
| Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC) | Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline) | Day 7 |
| Peak Change From Baseline in IC | Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments) | Day 7 (mean of 1 hr and 2 hr post-dose assessments) |
| Change From Baseline in Mean Morning Pre-dose Daily PEFR | Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1]) | Day 7 (60 minutes pre-dose, 30 minutes pre-dose) |
| Change From Baseline in Morning Post-dose Daily PEFR | Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1]) | Day 7 (30 minutes post-dose) |
| Change From Baseline in Mean Evening Pre-dose PEFR | Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment) | Day 7 |
| Change From Baseline in Mean Evening Post-dose PEFR | Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment) | Day 7 |
| Mean Number of Puffs of Rescue Medication | Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated | Day 7 |
| Change From Baseline in Morning Pre-dose Trough FEV1 | Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline) | Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline) |
| Peak Change From Baseline in FEV1 | Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline) | Day 14 |
| Change From Baseline for Mean Morning Pre-dose Trough IC | Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline) | Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline) |
| Peak Change From Baseline in IC | Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline) | Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline) |
| Change From Baseline in 12-hour Post-dose Trough FEV1 | 12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline | Day 14 (Baseline, 11.5 and 12 hours post dose) |
| Change From Baseline in Mean Morning Pre-dose Daily PEFR | Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1] | Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| Change From Baseline in Mean Morning Post-dose Daily PEFR | Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1] | Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| Change From Baseline in Mean Evening Pre-dose Daily PEFR | Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment) | Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| Change From Baseline in Mean Evening Post-dose Daily PEFR | Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment) | Through the end of the 14-Day Treatment |
| Mean Number of Puffs of Rescue Medication (End of Treatment) | Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated | Day 14 (End of treatment) |
| Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 | Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 | Day 1 through Day 14 |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Pearl Investigative Site | Panama City | Florida | 32405 | United States |
| Pearl Investigative Site | Tampa | Florida | 33603 | United States |
| Pearl Investigative Site | Winter Park | Florida | 32789 | United States |
| Pearl Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Pearl Investigative Site | Medford | Oregon | 97504 | United States |
| Pearl Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Pearl Investigative Site | Longview | Texas | 75605 | United States |
| Pearl Investigative Site | Richmond | Virginia | 23225 | United States |
| GP MDI 18 µg BID |
|
| GP MDI 9 µg BID |
|
| GP MDI 4.6 µg BID |
|
| GP MDI 2.4 µg BID |
|
| GP MDI 1.2 µg BID |
|
| GP MDI 0.6 µg BID |
|
| Placebo MDI |
|
| Spiriva® Handihaler® |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to Treat (ITT) Population: Subjects who randomized and received at least 1 dose of study drug, and had both baseline and post-baseline efficacy data for that treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | FEV1 AUC0-12 | Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days. | MITT (Modified Intent to Treat) Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 | Highest value of FEV1 post dose on day 1 | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Action (>10% Improvement in FEV1) on Day 1 | Time to Onset of Action (>10% Improvement in FEV1) on Day 1. | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Number | % of participants | Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs) |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving at Least 12% Improvement in FEV1 | Percentage of subjects achieving at least 12% improvement in FEV1. | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Number | Percentage of participants | Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in Inspiratory Capacity (IC) | Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 1 (1 hr and 2 hr post-dose ) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 | Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline) | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 | Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline) | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC) | Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline) | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in IC | Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments) | MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 7 (mean of 1 hr and 2 hr post-dose assessments) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Morning Pre-dose Daily PEFR | Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1]) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 (60 minutes pre-dose, 30 minutes pre-dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Post-dose Daily PEFR | Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1]) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 (30 minutes post-dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Pre-dose PEFR | Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Post-dose PEFR | Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Puffs of Rescue Medication | Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated | MITT Population | Posted | Mean | 95% Confidence Interval | Puffs | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 | Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 | Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Mean Morning Pre-dose Trough IC | Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in IC | Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 12-hour Post-dose Trough FEV1 | 12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 14 (Baseline, 11.5 and 12 hours post dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Morning Pre-dose Daily PEFR | Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1] | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Morning Post-dose Daily PEFR | Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1] | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Pre-dose Daily PEFR | Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Evening Post-dose Daily PEFR | Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment) | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | L/min | Through the end of the 14-Day Treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Puffs of Rescue Medication (End of Treatment) | Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated | MITT Population | Posted | Mean | 95% Confidence Interval | Puffs | Day 14 (End of treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 | Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 | MITT Population | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 through Day 14 |
|
All of the adverse events (AEs) reported during the study were captured after signing informed consent through the 7-14 day follow up period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GP MDI 18 µg BID | GP MDI 18 µg BID. | 0 | 64 | 2 | 64 | ||
| EG001 | GP MDI 9 µg BID | GP MDI 9 µg BID. | 1 | 64 | 3 | 64 | ||
| EG002 | GP MDI 4.6 µg BID | GP MDI 4.6 µg BID. | 0 | 62 | 3 | 62 | ||
| EG003 | GP MDI 2.4 µg BID | GP MDI 2.4 µg BID. | 1 | 64 | 6 | 64 | ||
| EG004 | GP MDI 1.2 µg BID | GP MDI 1.2 µg BID. | 0 | 57 | 3 | 57 | ||
| EG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. | 1 | 59 | 4 | 59 | ||
| EG006 | Placebo MDI | Placebo MDI. | 1 | 62 | 3 | 62 | ||
| EG007 | Spiriva 18 µg | Spiriva 18 µg | 1 | 62 | 6 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD, FCCP, FAAAAI | Pearl Therapeutics Inc | 650-305-2600 | creisner@pearltherapeutics.com |
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
GP MDI 1.2 µg BID.
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva Respimat | Spiriva Respimat 18 µg |
|
|
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| OG005 |
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 1.2 µg BID |
GP MDI 1.2 µg BID. |
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 1.2 µg BID |
GP MDI 1.2 µg BID. |
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
GP MDI 1.2 µg BID. |
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
|
|
| OG005 | GP MDI 0.6 µg BID | GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|
| GP MDI 0.6 µg BID |
GP MDI 0.6 µg BID. |
| OG006 | Placebo MDI | Placebo MDI. |
| OG007 | Spiriva® Handihaler® | Spiriva® Handihaler® (Tiotropium Bromide). |
|
|