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This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this study, airway dimension parameters will be calculated for each of the active compounds.
This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGF-GFF | Experimental | Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate |
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| GFF-BGF | Experimental | Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGF | Combination Product | Treatment with Budesonide/Glycopyrronium/FormoterolFumarate |
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| Measure | Description | Time Frame |
|---|---|---|
| Specific Image-based Airway Volume (siVaw) | Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline. | Baseline, Day 29 |
| Specific Image-based Airway Resistance (siRaw) | Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline. | Baseline, Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Image-based Airway Volume (iVaw) | Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline. | Baseline, Day 29 |
| Image-based Airway Resistance (iRaw) |
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Inclusion Criteria:
Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1.
Exclusion Criteria:
As judged by the investigator, any evidence of significant diseases other than COPD, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial.
Spirometry Performance:
Cancer: Subjects who have cancer that has not been in complete remission for at least five years.
Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse alcohol or drugs
Subjects who in the opinion of the investigator are unable to abstain from prohibited medications including LABA/LAMAs/ICS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Erpent | 5101 | Belgium | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34210340 | Derived | van den Berge M, De Backer J, Van Holsbeke C, De Backer W, Trivedi R, Jenkins M, Dorinsky P, Aurivillius M. Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids. Respir Res. 2021 Jul 1;22(1):191. doi: 10.1186/s12931-021-01772-2. |
| Label | URL |
|---|---|
| Statistical Analysis Plan (SAP) | View source |
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Subjects were randomized into 1 of 2 treatment sequences. Sequence 1 received BGF MDI in Period 1 followed by GFF MDI in Period 2. Sequence 2 received GFF MDI in Period 1 followed by BGF MDI in Period 2.
This study randomized 23 subjects at 4 study centers (1 center in Belgium and 3 centers in the Netherlands) from Feb 2019 to Nov 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | BGF MDI/GFF MDI | Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation |
| FG001 | GFF MDI/BGF MDI |
| 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 | Jul 5, 2019 | Nov 10, 2020 |
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| GFF | Combination Product | Treatment with Glycopyrronium/Formoterol Fumarate |
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Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline.
| Baseline, 29 Days |
| Forced Expiratory Volume in One Second (Post-dose FEV1). | Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1). | Baseline 29 Days |
| Functional Residual Capacity (FRC) | Change from baseline in Functional residual capacity (FRC). | Baseline, Day 29 |
| Eindhoven |
| 5623 EJ |
| Netherlands |
| Research Site | Groningen | 9713 GZ | Netherlands |
| Research Site | Zutphen | 7207 AE | Netherlands |
| CSP | View source |
Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation followed by Washout and then Budesonide/Glycopyrronium/Formoterol Metered Dose Inhalation
| 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.
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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 (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | Ratio to baseline | Baseline, Day 29 |
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| Primary | Specific Image-based Airway Resistance (siRaw) | Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | Ratio to baseline | Baseline, Day 29 |
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| Secondary | Image-based Airway Volume (iVaw) | Image-based Airway Volume (iVaw) measured in mL. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | Ratio to baseline | Baseline, Day 29 |
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| Secondary | Image-based Airway Resistance (iRaw) | Image-based airway resistance (iRaw) measured in kPa∙s/L. Average across lobes, without adjustment for lobe volume. Reported as ratio to baseline. | ITT Population | Posted | Geometric Mean | 95% Confidence Interval | Ratio to baseline | Baseline, 29 Days |
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| Secondary | Forced Expiratory Volume in One Second (Post-dose FEV1). | Change from baseline in Forced Expiratory Volume in One Second (Post-dose FEV1). | ITT Population | Posted | Mean | 95% Confidence Interval | L | Baseline 29 Days |
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| Secondary | Functional Residual Capacity (FRC) | Change from baseline in Functional residual capacity (FRC). | ITT Population | Posted | Mean | 95% Confidence Interval | L | Baseline, Day 29 |
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Adverse events were collected from visit 2 throughout the treatment period and including the follow-up period telephone call.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events were collected visit 2 throughout the treatment period and including the follow-up period telephone call.
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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 | BGF MDI | Budoesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation | 0 | 22 | 1 | 22 | 0 | 22 |
| EG001 | GFF MDI | Glycopyrronium/Formoterol Fumarate Metered Dose Inhalation | 0 | 23 | 0 | 23 | 2 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca AB | AstraZeneca AB | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2019 | Jan 25, 2021 | SAP_002.pdf |
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| 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 |
| 1.53 |
| 2-Sided |
| 95 |
| 1.28 |
| 1.83 |
| Other |
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