A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
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| ClinicalTrials.gov Identifier: NCT02727660 |
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Recruitment Status :
Completed
First Posted : April 4, 2016
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
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Sponsor:
Pearl Therapeutics, Inc.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Chronic Obstructive Pulmonary Disorder |
| Interventions |
Drug: BFF MDI (PT009) 320/9.6 μg Drug: BFF MDI (PT009) 160/9.6 μg Drug: FF MDI (PT005) 9.6 μg |
| Enrollment | 1876 |
Participant Flow
| Recruitment Details | This study screened subjects at 292 study centers in 18 countries and randomized subjects at 259 study centers, from April 2016 to April 2018. |
| Pre-assignment Details | Subjects were randomized in a 1:1:1 ratio to BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and FF MDI 9.6 μg treatment groups |
| Arm/Group Title | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug |
|---|---|---|---|
 Arm/Group Description |
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug | Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug | Formoterol Fumarate Metered dose inhalation 9.6 ug |
| Period Title: Overall Study | |||
| Started [1] | 619 | 617 | 607 |
| Completed [2] | 503 | 501 | 442 |
| Not Completed | 116 | 116 | 165 |
| Reason Not Completed | |||
| Lack of Efficacy | 40 | 40 | 70 |
| Adverse Event | 28 | 21 | 32 |
| Withdrawal by Subject | 26 | 25 | 30 |
| Physician Decision | 3 | 8 | 14 |
| Lost to Follow-up | 5 | 9 | 8 |
| Protocol Violation | 7 | 5 | 5 |
| Protocol Specified Disc. Criteria | 5 | 5 | 2 |
| Administrative Reasons | 2 | 3 | 4 |
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[1]
mITT Population
[2]
Completed Study Treatment
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Baseline Characteristics
| Arm/Group Title | BFF MDI 320/9.6 ug | BFF MDI 160/9.6 ug | FF MDI 9.6 ug | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Budesonide Formoterol Fumarate Metered dose inhalation 320/9.6 ug | Budesonide Formoterol Fumarate Metered dose inhalation 160/9.6 ug | Formoterol Fumarate Metered dose inhalation 9.6 ug | Total of all reporting groups | |
| Overall Number of Baseline Participants | 629 | 630 | 617 | 1876 | |
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Baseline Analysis Population Description |
The Intent-To-Treat (ITT) Population is defined as all subjects who were randomized to treatment (presented here). The Modified Intent-To-Treat (mITT) Population, a subset of the ITT Population, is defined as all subjects with post-randomization data obtained prior to d/c from treatment. The mITT Population was used for all efficacy analyses.
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 619 participants | 617 participants | 607 participants | 1843 participants | |
| 65.3 (8.1) | 64.5 (8.4) | 64.8 (8.5) | 64.9 (8.3) | ||
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[1]
Measure Analysis Population Description: mITT Population
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 619 participants | 617 participants | 607 participants | 1843 participants | |
| Female |
252 40.7%
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272 44.1%
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268 44.2%
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792 43.0%
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| Male |
367 59.3%
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345 55.9%
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339 55.8%
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1051 57.0%
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[1]
Measure Analysis Population Description: mITT Population
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 619 participants | 617 participants | 607 participants | 1843 participants | |
| Hispanic or Latino |
190 30.7%
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200 32.4%
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190 31.3%
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580 31.5%
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| Not Hispanic or Latino |
423 68.3%
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414 67.1%
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412 67.9%
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1249 67.8%
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| Unknown or Not Reported |
6 1.0%
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3 0.5%
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5 0.8%
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14 0.8%
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[1]
Measure Analysis Population Description: mITT Population
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 619 participants | 617 participants | 607 participants | 1843 participants | |
| American Indian or Alaska Native |
26 4.2%
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18 2.9%
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24 4.0%
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68 3.7%
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| Asian |
1 0.2%
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7 1.1%
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4 0.7%
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12 0.7%
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| Native Hawaiian or Other Pacific Islander |
1 0.2%
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0 0.0%
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0 0.0%
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1 0.1%
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| Black or African American |
30 4.8%
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22 3.6%
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29 4.8%
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81 4.4%
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| White |
514 83.0%
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516 83.6%
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504 83.0%
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1534 83.2%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
47 7.6%
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54 8.8%
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46 7.6%
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147 8.0%
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[1]
Measure Analysis Population Description: mITT Population
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Paul M. Dorinsky, MD |
| Organization: | Pearl Therapeutics, a Member of the AstraZeneca Group |
| Phone: | 650-305-2600 |
| EMail: | paul.dorinsky1@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pearl Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02727660 |
| Other Study ID Numbers: |
PT009003 |
| First Submitted: | March 30, 2016 |
| First Posted: | April 4, 2016 |
| Results First Submitted: | May 22, 2019 |
| Results First Posted: | September 26, 2019 |
| Last Update Posted: | September 26, 2019 |