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To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP MDI (PT001) 14.4 μg | Experimental | Glycopyrronium |
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| FF MDI (PT005) 9.6 μg | Experimental | Formoterol Fumarate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP MDI (PT001) 14.4 μg | Drug | Glycopyrronium |
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| Measure | Description | Time Frame |
|---|---|---|
| Specific Image-Based Airway Volume (siVaw) | Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline | Baseline, Day 15 |
| Specific Image-based Airway Resistance (siRaw) | Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline. | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Image-based Airway Volume (iVaw) | Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline. | Baseline, Day 15 |
| Image-based Airway Resistance (iRaw) | Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Orevillo | Pearl Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edegem | 2650 | Belgium | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received GP MDI in Period 1 followed by FF MDI in Period 2. Sequence 2 received FF MDI in Period 1 followed by GP MDI in Period 2.
This study randomized 23 subjects at 2 sites in Belgium from December 2016 to May 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | GP MDI/ FF MDI | Glycopyrronium Metered Dose Inhalation /Formoterol Fumarate Metered Dose Inhalation |
| FG001 | FF MDI/GP MDI | Formoterol Fumarate Metered Dose Inhalation / Glycopyrronium Metered Dose Inhalation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2016 | May 10, 2019 |
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| FF MDI (PT005) 9.6 μg |
| Drug |
Formoterol Fumarate |
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| Baseline, Day 15 |
| FEV1 | FEV1 Change from baseline in Forced Expiratory Volume at 1 second. | Baseline, Day 15 |
| Functional Residual Capacity (FRC) | Functional residual capacity (FRC). Ratio to baseline. | Baseline, Day 15 |
| Erpent |
| 5101 |
| Belgium |
| COMPLETED |
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| NOT COMPLETED |
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| Washout |
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| Period 2 |
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ITT Population - all subjects who were randomized to treatment. Treatment was assigned as randomized regardless of the treatment actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | ITT Population |
| 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 | ITT Population | Mean | Standard Deviation | Years |
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| Sex: Female, Male | ITT Population | Count of Participants | Participants |
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| Race (NIH/OMB) | ITT Population | 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 | Specific Image-Based Airway Volume (siVaw) | Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Day 15 |
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| Primary | Specific Image-based Airway Resistance (siRaw) | Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Day 15 |
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| Secondary | Image-based Airway Volume (iVaw) | Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Day 15 |
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| Secondary | Image-based Airway Resistance (iRaw) | Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Day 15 |
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| Secondary | FEV1 | FEV1 Change from baseline in Forced Expiratory Volume at 1 second. | ITT Population | Posted | Mean | Standard Deviation | L | Baseline, Day 15 |
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| Secondary | Functional Residual Capacity (FRC) | Functional residual capacity (FRC). Ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | ratio | Baseline, Day 15 |
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Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.
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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 | GP MDI | Glycopyrronium Metered Dose Inhalation | 0 | 20 | 1 | 20 | 3 | 20 |
| EG001 | FF MDI | FF MDI Formoterol Fumarate Metered Dose Inhalation | 0 | 22 | 1 | 22 | 3 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Aortic Aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | 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 it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Stenglein, MD | AstraZeneca | +46 (0)31 776 1000 | stephan.stenglein@astrazeneca.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2018 | May 10, 2019 | SAP_001.pdf |
| 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| t-test, 2 sided |
Within-group comparison to baseline using paired test |
| <0.0001 |
Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment |
| Geometric mean ratio to baseline |
| 1.23 |
| 2-Sided |
| 95 |
| 1.14 |
| 1.33 |
| Other |
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