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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 demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 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 |
|
| PT001 MDI (Dose 2) | Experimental | PT001 MDI |
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| PT001 MDI (Dose 3) | Experimental | PT001 MDI |
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| PT001 MDI (Dose 4) | Experimental | PT001 MDI |
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| Ipratropium Bromide HFA Inhalation Aerosol | Active Comparator | Ipratropium Bromide HFA Inhalation Aerosol |
|
| Placebo MDI | Placebo Comparator | PT001 Placebo MDI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT001 MDI | Drug | PT001 MDI administered as two puffs BID for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 AUC0-12 | FEV1 AUC0-12 following chronic dosing (1 week), normalized. | Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Change From Baseline in FEV1 on Day 1 | Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted) | Day 1 |
| Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1 | Time to onset of action ( ≥10% improvement in FEV1) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria as defined in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, M.D. | Pearl Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Panama City | Florida | United States | |||
| Pearl Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29506504 | Derived | Kerwin EM, Spangenthal S, Kollar C, St Rose E, Reisner C. A phase IIb randomized, chronic-dosing, incomplete block, cross-over study of glycopyrronium, delivered via metered dose inhaler, compared with a placebo and an active control in patients with moderate-to-severe COPD. Respir Res. 2018 Mar 5;19(1):38. doi: 10.1186/s12931-018-0739-6. |
| Label | URL |
|---|---|
| Related Info | View source |
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This was a chronic dosing study (7 days), 3-period, 6-treatment, incomplete block, crossover study. Each subject received 3 of 6 possible treatments; each treatment period was separated by a washout period 7-28 days. By-treatment sequence tabulations of the data were not pre-specified.
Conducted at 9 US sites from May-October 2011. Entire period of study participation per subject was a maximum of 15 weeks. Planned target enrollment of 84 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Randomized |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ipratropium Bromide HFA Inhalation Aerosol | Drug | Taken as 2 inhalations of the 17 µg per actuation strength MDI QID |
|
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| Placebo MDI | Other | Matching placebo to PT001 MDI administered as two puffs BID for 7 days |
|
| Day 1 (15 min, 30 min, 1 hour, 2 hours) |
| Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline) | Day 1 |
| Peak Change From Baseline in IC on Day 1 | Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1) | Day 1 |
| Change From Baseline in Morning Pre-dose FEV1 on Day 7 | Change from baseline in morning pre-dose FEV1 | Day 7 |
| Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 | Day 7 |
| Peak Change From Baseline in IC on Day 7 | Peak change from baseline in IC | Day 7 |
| Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline in 12-hour post-dose trough FEV1 | Day 7 |
| Winter Park |
| Florida |
| United States |
| Pearl Investigative Site | Cherry Hill | New Jersey | United States |
| Pearl Investigative Site | Summit | New Jersey | United States |
| Pearl Investigative Site | Charlotte | North Carolina | United States |
| Pearl Investigative Site | Medford | Oregon | United States |
| Pearl Investigative Site | Longview | Texas | United States |
| Pearl Investigative Site | Richmond | Virginia | United States |
| GP MDI 36 µg BID |
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| GP MDI 18 µg BID |
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| GP MDI 9 µg BID |
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| GP MDI 4.6 µg BID |
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| Placebo MDI BID |
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| Atrovent HFA 34 µg BID |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | ITT Population | ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | FEV1 AUC0-12 | FEV1 AUC0-12 following chronic dosing (1 week), normalized. | Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours) |
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| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 on Day 1 | Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted) | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1 | Time to onset of action ( ≥10% improvement in FEV1) | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Number | % of subjects | Day 1 (15 min, 30 min, 1 hour, 2 hours) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline) | MITT Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Number | Percent | Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in IC on Day 1 | Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1) | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning Pre-dose FEV1 on Day 7 | Change from baseline in morning pre-dose FEV1 | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Change From Baseline in IC on Day 7 | Peak change from baseline in IC | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Day 7 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline in 12-hour post-dose trough FEV1 | MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Day 7 |
|
Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
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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 | PT001 MDI 36 µg BID | PT001 MDI 36 µg BID. | 0 | 49 | 1 | 49 | ||
| EG001 | PT001 MDI 18 µg BID | PT001 MDI 18 µg BID. | 0 | 49 | 2 | 49 | ||
| EG002 | PT001 MDI 9 µg BID | PT001 MDI 9 µg BID | 0 | 49 | 4 | 49 | ||
| EG003 | PT001 MDI 4.6 µg BID | PT001 MDI 4.6 µg BID. | 1 | 45 | 4 | 45 | ||
| EG004 | Ipratropium Bromide HFA Inhalation Aerosol | Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID. | 1 | 48 | 3 | 48 | ||
| EG005 | Placebo BID | Placebo BID. | 0 | 48 | 1 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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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 |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID. |
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
|
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
|
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
| OG005 | Placebo MDI BID | Placebo MDI BID. |
|
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