INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
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ClinicalTrials.gov Identifier: NCT03467425 |
Recruitment Status :
Completed
First Posted : March 16, 2018
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Pulmonary Disease, Chronic Obstructive |
Interventions |
Drug: FF/UMEC/VI Drug: Inhaled Corticosteroid Drug: LAMA Drug: LABA Drug: COPD rescue medications |
Enrollment | 3109 |
Participant Flow
Recruitment Details | This was a Phase IV, open-label, randomized study to evaluate the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA multiple inhaler triple therapies (MITT) for chronic obstructive pulmonary disease (COPD) control within the usual clinical practice setting. TRELEGY and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies. |
Pre-assignment Details | A total of 3341 participants were screened and 3109 participants (Par.) were enrolled in this study. Of which, 3092 participants were randomized and received the study treatment. The remaining 17 participants were randomized in error (those who were recorded as screen failures and also randomized) and did not receive investigational product (IP). |
Arm/Group Title | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT |
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Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. | Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. |
Period Title: Overall Study | ||
Started | 1545 | 1547 |
Randomized But Did Not Start IP | 1 | 0 |
Completed IP | 1256 | 1359 |
Not Completed IP | 288 | 188 |
Withdrew IP (WIP): Lost to Follow-up | 15 | 24 |
WIP: Protocol Deviation | 0 | 2 |
WIP: Adverse Event | 112 | 29 |
WIP: Lack of Efficacy | 56 | 28 |
WIP: Physician Decision | 14 | 27 |
WIP: Withdrawal by Participant | 91 | 78 |
Completed | 1498 | 1493 |
Not Completed | 47 | 54 |
Reason Not Completed | ||
Adverse Event | 9 | 9 |
Lack of Efficacy | 3 | 1 |
Protocol Violation | 0 | 1 |
Lost to Follow-up | 18 | 25 |
Physician Decision | 2 | 1 |
Withdrawal by Subject | 15 | 17 |
Baseline Characteristics
Arm/Group Title | FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI | Non-ELLIPTA MITT | Total | |
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Eligible participants received a combination of fluticasone furoate (FF) blended with lactose in the first strip (100 microgram [mcg] per blister); and umeclidinium bromide (UMEC) and vilanterol (VI) blended with lactose and magnesium stearate in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the same TRELEGY ELLIPTA dry powder inhaler (DPI) via inhalation route for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. | Eligible participants received the inhaled corticosteroid (ICS)/long-acting muscarinic receptor antagonist (LAMA)/long-acting beta agonist (LABA) products twice daily as prescribed by the physician for a period of 24 weeks. Participants were administered other prescribed COPD medications such as rescue medications according to usual practice, as suggested by physician. | Total of all reporting groups | |
Overall Number of Baseline Participants | 1545 | 1547 | 3092 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 1545 participants | 1547 participants | 3092 participants | |
67.8 (8.78) | 67.8 (8.59) | 67.8 (8.68) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1545 participants | 1547 participants | 3092 participants | |
Female |
708 45.8%
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729 47.1%
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1437 46.5%
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Male |
837 54.2%
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818 52.9%
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1655 53.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1545 participants | 1547 participants | 3092 participants | |
Asian- Central/South Asian Heritage |
12 0.8%
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7 0.5%
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19 0.6%
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Asian- East Asian Heritage |
0 0.0%
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1 0.1%
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1 0.0%
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Asian- South East Asian Heritage |
1 0.1%
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6 0.4%
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7 0.2%
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Black or African American |
3 0.2%
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4 0.3%
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7 0.2%
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White- Arabic/North African Heritage |
6 0.4%
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7 0.5%
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13 0.4%
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White- White/Caucasian/European Heritage |
1523 98.6%
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1521 98.3%
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3044 98.4%
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White and Black or African American |
0 0.0%
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1 0.1%
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1 0.0%
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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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT03467425 |
Other Study ID Numbers: |
206854 2017-004369-29 ( EudraCT Number ) |
First Submitted: | February 2, 2018 |
First Posted: | March 16, 2018 |
Results First Submitted: | August 19, 2020 |
Results First Posted: | September 7, 2020 |
Last Update Posted: | September 7, 2020 |